Endoscopic laser ablation as palliative treatment of endobronchial, nonresectable, or recurrent lung cancer: assessment of its impact on quality of life

Laser ablation (LA) is currently used in our institute as palliative treatment for endobronchial nonresectable or recurrent lung cancer. The objective of this study was to assess the impact of LA on the quality of life (QOL) in a large group of patients with endobronchial obstructions due to nonresectable or re-current lung cancer. Evaluation was based on Eastern Cooperative Oncology Group performance status (ECOG PS) for the "objective" assessment of QOL and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 version 1.0 (EORTC QLQ-C30(v1)) for the "subjective" assessment of QOL. From May 1994 to June 1997, 133 LAs were performed using neodymium: yttrium-aluminum garnet (Nd:YAG) laser at low power settings (< 30W) on 89 evaluable patients (Male/Female 78/11, mean age 63.5/62.8 years, range 42-82/47-73). The QOL was evaluated by ECOG PS and QLQ-C30(v1) at baseline (3 days before LA), t1 (7 days after LA), and t2 (1 month after LA). The objective tumor response was evaluated at t2. The objective tumor response to LA intervention was "excellent," ie, complete response (CR), in 33 (24.8%) patients and "fair," ie, partial response (PR), in 97 (72.9%) patients, with an overall response rate (ORR) of 97.7%. A highly significant decrease in high score (ECOG PS 3-4) was registered from baseline to t1 and from t1 to t2. However, at the same time a significant increase of low score (ECOG PS 0-2) was observed. The comparison of patient QOL assessment by QLQ-C30(v1) at different times during the study was also made; the functioning scales, the global QOL scale, and the symptom scales/items showed a highly significant improvement at t1 compared to baseline (P < 0.001), whereas only global QOL improved at t2 compared to t1. A comparison of baseline ECOG PS scale with QLQ-C30(v1) scale revealed a strong relationship between PS and the symptom "fatigue." Our study demonstrates that dramatic clinical improvement obtained by an effective though palliative treatment such as LA improves QOL based on both physician-rated (PS) and mostly self-rated (QLQ-C30(v1)) assessment.     

Prognosis of metastatic renal cell carcinoma with first‐line interferon‐α therapy in the era of molecular‐targeted therapy

The RCC‐SELECT study showed the correlation between single nucleotide polymorphisms (SNP) in STAT3 gene and survival in metastatic renal cell carcinoma (mRCC) patients with first‐line interferon‐α (IFN‐α). In that study, even patients with STAT3 SNP linked to shorter overall survival (OS) exhibited remarkably improved prognosis. All 180 patients evaluated in the above study were further analyzed for correlation between OS and demographics/clinicopathological parameters. OS was estimated using the Kaplan–Meier method. Associations between OS and potential prognostic factors were assessed using the log‐rank test and the Cox proportional hazards model. The median OS was 42.8 months. Univariate analysis showed that worse Eastern Cooperative Oncology Group‐performance status (ECOG‐PS), high T stage, regional lymph node metastasis, distant metastasis, higher grade, infiltrative growth pattern, the presence of microscopic vascular invasion (MVI), hypercalcemia, anemia, thrombocytopenia and elevated C‐reactive protein were significantly associated with OS. Multivariate analysis revealed that ECOG‐PS (hazard ratio [HR] = 3.665, P = 0.0004), hypercalcemia (HR = 6.428, P = 0.0005) and the presence of MVI (HR = 2.668, P = 0.0109) were jointly significant poor prognostic factors. This is the first study analysing prognostic factors of mRCC patients with first‐line IFN‐α using large cohort of the prospective study. The present study suggests that first‐line IFN‐α is still a useful therapy for mRCC even in the era of molecular targeted therapy.     

Can older cancer patients tolerate chemotherapy? A prospective pilot study

BACKGROUND: To the authors' knowledge, few data currently are available regarding the tolerance to chemotherapy in older cancer patients. This prospective pilot study evaluated the changes in functional, mental, nutritional, and comorbid status, as well as the quality of life (QOL), in geriatric oncology patients receiving chemotherapy. METHODS: Sixty patients age > or = 70 years who were undergoing cancer chemotherapy were recruited in a university-based comprehensive cancer center. Changes in physical function were measured by the Eastern Cooperative Oncology Group performance status (ECOG PS) and Instrumental Activities of Daily Living (IADLs), mental health changes were measured by the Mini-Mental State Examination and the Geriatric Depression Scale (GDS), comorbidity was measured by Charlson's index and the Cumulative Illness Rating Scale-Geriatric, nutrition was measured by the Mini-Nutritional Assessment, and QOL was measured by the Functional Assessment of Cancer Therapy-General (FACT-G). Changes were assessed at baseline and at the end of treatment (EOT). Grade 4 hematologic and Grade 3-4 nonhematologic toxicities were recorded. RESULTS: Thirty-seven patients (63%) completed both assessments. Older cancer patients demonstrated a significant decline in measurements of physical function after receiving chemotherapy, as indicated by changes in scores on the IADL (P = 0.04) and on the physical (P = 0.01) and functional (P = 0.03) subscales of the FACT-G. They also displayed worse scores on the GDS administered postchemotherapy (P < 0.01). Patients who experienced severe chemotoxicity had more significant declines in ECOG PS (P = 0.03), IADL (P = 0.03), and GDS (P = 0.04), and more gain in the social well-being subscale (P = 0.02) of the FACT-G, than those who did not experience severe chemotoxicity. However, changes in most scores were small in magnitude clinically. No significant change was found between baseline and EOT in nutrition, comorbidity, and other aspects of the FACT-G. CONCLUSIONS: Older cancer patients undergoing chemotherapy may experience toxicity but generally can tolerate it with limited impact on independence, comorbidity, and QOL levels. It is important to recognize and monitor these changes during geriatric oncology treatment.     

Quality of life in women with advanced breast cancer treated with docetaxel

A survey was conducted to address the question of whether overall quality of life (QOL) in women with advanced breast cancer is significantly impaired by treatment with docetaxel in routine clinical practice. Health-related QOL (HRQOL) measured by the European Organisation for Research and Treatment of Cancer QOL Questionnaire C30, as well as performance status (PS) and tumor response, were assessed at baseline, then after every 2 cycles of treatment. The 209 evaluable patients received a median of 5 treatment cycles (range, 2-9), with a response rate of 35% (95% CI, 28.5%-41.4%). There were significant adverse changes in fatigue (P = 0.002) and diarrhea (P = 0.0002). However, HRQOL scores for emotional function (P < 0.0001), pain (P = 0.0001), constipation (P = 0.01), and nausea and vomiting (P = 0.03) all showed significant beneficial changes. Several QOL parameters improved during docetaxel therapy even in patients who did not have an objective tumor response. Overall, PS was maintained during docetaxel treatment. Following the encouraging QOL data from clinical trials of docetaxel in breast cancer, the authors conclude that, in actual clinical practice, docetaxel does not have an overall detrimental effect on QOL.     

Clinical benefits of once-weekly epoetin alfa in anemic patients with colorectal cancer receiving chemotherapy

In a large, 16-week, prospective study of 2,964 anemic patients with various cancers undergoing chemotherapy, once-weekly subcutaneous administration of 40,000 U of epoetin alfa,with potential escalation to 60,000 U, increased hemoglobin (Hgb) levels, decreased transfusion requirements, and improved quality of life (QOL) as assessed using the Linear Analog Scale Assessment (LASA) for energy, activity, and overall QOL and the Functional Assessment in Cancer Therapy-Anemia (FACT-An) QOL instrument. A retrospective subset analysis conducted in 244 colorectal cancer patients enrolled in the study showed statistically significant improvements from baseline to final readings in LASA energy, activity, and overall QOL and FACT-An Anemia Symptoms and Fatigue subscale scores (P < 0.02). Moreover, patients who achieved larger improvements in Hgb levels also demonstrated greater percentage improvements in QOL over baseline measurements. Mean Hgb levels increased by 1.2 g/dL after 4 weeks of treatment and by 1.6 g/dL by study end, independent of red blood cell transfusion within 28 days prior to the Hgb assessment. Hematopoietic response (Hgb level > or = 12 g/dL and/or increase in Hgb level > or = 2 g/dL, independent of transfusion) was observed in 61% of patients (139/229). Additionally, the proportion of patients receiving transfusions decreased from 17% at baseline to 4% during the final month of therapy. Epoetin alfa was well tolerated, with no evidence of unexpected adverse events. Except for significantly higher QOL scores at baseline, results for the cohort of colorectal cancer patients were similar to those for patients with other cancer types in the main study population.     

Relationship between neurocognitive function and quality of life after whole-brain radiotherapy in patients with brain metastasis

PURPOSE: To examine the relationship between neurocognitive function (NCF) and quality of life (QOL) in patients with brain metastases after whole-brain radiotherapy. PATIENTS AND METHODS: A total of 208 patients from the whole-brain radiotherapy arm of a Phase III trial (PCI-P120-9801), who underwent regular NCF and QOL (ADL [activities of daily living] and FACT-Br [Functional Assessment of Cancer Therapy-Brain-specific]) testing, were analyzed. Spearman's rank correlation was calculated between NCF and QOL, using each patient's own data, at each time point. To test the hypothesis that NCF declines before QOL changes, the predictive effect of NCF from previous visits on QOL was studied with a linear mixed-effects model. Neurocognitive function or QOL deterioration was defined relative to each patient's own baseline. Lead or lag time, defined as NCF deterioration before or after the date of QOL decline, respectively, was computed. RESULTS: At baseline, all NCF tests showed statistically significant correlations with ADL, which became stronger at 4 months. A similar observation was made with FACT-Br. Neurocognitive function scores from previous visits predicted ADL (p < 0.05 for seven of eight tests) or FACT-Br. Scores on all eight NCF tests deteriorated before ADL decline (net lead time 9-153 days); and scores on six of eight NCF tests deteriorated before FACT-Br (net lead time 9-82 days). CONCLUSIONS: Neurocognitive function and QOL are correlated. Neurocognitive function scores from previous visits are predictive of QOL. Neurocognitive function deterioration precedes QOL decline. The sequential association between NCF and QOL decline suggests that delaying NCF deterioration is a worthwhile treatment goal in brain metastases patients.     

Performance status and cytoreductive nephrectomy: redefining management in patients with poor performance

BACKGROUND.

An Eastern Cooperative Oncology Group performance status (ECOG PS) of 2/3 can quantify cancer patients' well being and may be used to select patients for treatment. The objective of the current study was to investigate the outcomes of cytoreductive nephrectomy (CN) for patients who have an impaired performance status (ECOG PS 2/3).

METHODS.

Patients who underwent CN for renal cell carcinoma (RCC) between 1989 and 2006 were identified. Patient records were reviewed for age, symptoms, ECOG PS, tumor size, stage, grade, histology, sarcomatoid features, lymph node metastasis, site of metastasis, and the presence of bone metastases (BM) in weight‐bearing structures. The relation of ECOG PS to outcome variables was evaluated.

RESULTS.

Four hundred eighteen patients underwent CN, including 117 patients who had an ECOG PS of 0, 274 patients who had an ECOG PS of 1, and 27 patients who had an ECOG PS of 2/3. Patients who had a worse ECOG PS were younger, had higher tumor classification and grade, and more frequently demonstrated anemia and BM. Only 37.5% of patients who had an ECOG PS of 2/3 experienced an improvement in performance in the postoperative period, and only 57.5% went on to receive systemic therapy, of whom none attained an objective responses. The median disease‐specific survival for patients who had an ECOG PS of 0, 1, and 2/3 was 27 months, 13.8 months, and 6.6 months, respectively (P<.001). Patients who had an ECOG PS of 2/3 could be stratified further by the presence or absence of BM into 2 groups (median disease‐specific survival: 17.7 months and 2.1 months, respectively; P = .006).

CONCLUSIONS.

Surgery in patients who have a poor performance may serve a palliative function but should be performed with caution because of the poor outcome of such patients. ECOG PS is influenced strongly by BM. A subset of patients with an ECOG PS of 2/3 that are symptomatic specifically from BM may derive greater benefit from CN than patients who hare symptomatic because of visceral metastases. Cancer 2008. © 2008 American Cancer Society.     

Once-weekly dosing of epoetin-alpha increases hemoglobin and improves quality of life in anemic cancer patients receiving radiation therapy either concomitantly or sequentially with chemotherapy

BACKGROUND: The current study was performed to prospectively evaluate the effectiveness, clinical outcomes, and safety of once-weekly (QW) recombinant human erythropoietin (r-HuEPO [epoetin-alpha]) in anemic cancer patients with nonmyeloid malignancies who were receiving radiation therapy (RT) concomitantly or sequentially with chemotherapy (CT). METHODS: A total of 777 anemic patients (hemoglobin [Hb] < or = 11 g/dL) were enrolled in this multicenter, open-label, nonrandomized, 16-week study. Patients initially received epoetin-alpha at a dose of 40,000 units (U) subcutaneously QW, escalating to a dose of 60,000 U QW if the Hb increased to < or = 1 g/dL after 4 weeks. Endpoints were changes in hematologic and quality of life (QOL) parameters. RESULTS: Among the 442 patients evaluable for hematologic response, the mean increase in Hb from baseline to the time of final evaluation was 1.9 +/- 1.8 g/dL (P < 0.05). An increase in Hb of > or = 2 g/dL, in the absence of blood transfusions, occurred in 68.3% of patients (278 of 407 patients) who were on the study for > or = 30 days. The overall response rate (Hb increase > or = 2 g/dL or Hb > or = 12 g/dL in the absence of blood transfusions) was 74.0% (301 of 407 patients). In 359 patients who were evaluable for QOL assessment, epoetin-alpha therapy was found to significantly (P < 0.05) improve mean Linear Analog Scale Assessment (LASA) scores for energy level, ability to perform daily activities, and overall QOL from baseline to the time of final evaluation. QW epoetin-alpha therapy was found to be well tolerated. CONCLUSIONS: Treatment with QW epoetin-alpha was found to increase Hb levels, decrease transfusion requirements, and improve functional status and QOL in anemic patients with nonmyeloid malignancies who were receiving RT concomitantly or sequentially with CT. Clinical benefits and the safety profile of QW epoetin-alpha in this setting appear to be similar to those observed in anemic cancer patients receiving CT.     

Impact of clinicopathological characteristics on survival in patients treated with immune checkpoint inhibitors for metastatic melanoma

Immune checkpoint inhibitors (ICIs) have unprecedented effects on the treatment of metastatic melanoma. However, little is known about the prognostic values of various clinicopathological characteristics. Here, PubMed, Embase and Cochrane database were searched from inception to April 2018 for random controlled trials (RCTs) that compared ICIs with controls. The hazard ratios (HRs) for overall survival (OS) according to gender, age, Eastern Cooperative Oncology Group (ECOG) performance status (PS), lactate dehydrogenase (LDH) level and metastasis stage were extracted. Four phase III RCTs involving 1,598 patients with metastatic melanoma were included in this study. Compared with conventional agents, ICIs were associated with prolonged OS (HR, 0.67; 95% CI, 0.50–0.88; p = 0.005). The pooled OS HR was 0.60 (95% CI, 0.42–0.84; p = 0.003) in men; 0.84 (95% CI, 0.69–1.01; p = 0.07) in women. The difference in efficacy between men and women was significant (p_interaction = 0.03). The OS HR was 0.59 (95% CI, 0.41–0.83; p = 0.003) in patients >65 years old; 0.74 (95% CI, 0.55–1.01; p = 0.054) in patients <65 years old. The OS HR was 0.75 (95% CI, 0.60–0.94; p = 0.01) in patients with ECOG PS = 1; 0.64 (95% CI, 0.38–1.06; p = 0.08) in patients with ECOG PS = 0. Additionally, the long-term benefits were independent of metastasis stage and LDH level. In summary, although immunotherapy significantly prolongs OS in metastatic melanoma, the long-term benefits in women, younger patients (<65 years old) and patients with ECOG PS = 0 were marginal. These results may assist in treatment decision-making, design and interpretation of clinical trials and economic analyses.     

Single-Agent Epidermal Growth Factor Receptor Inhibitor Gefitinib for the Treatment of Patients with Advanced Non—Small-Cell Lung Cancer and Poor Performance Status

PurposePatients with advanced non—small-cell lung cancer (NSCLC) have no options for curative therapy; therefore, improving their quality of life (QOL) is also an important treatment goal. Patients with NSCLC and poor performance status (PS) are often excluded from clinical trials. Gefitinib, an epidermal growth factor (EGFR) inhibitor, is a safe oral agent that might benefit these patients. The aim of the study is to evaluate the effect of single-agent EGFR inhibitor gefitinib on the QOL of patients with advanced NSCLC and poor PS.Patients and MethodsNineteen patients with advanced NSCLC and poor PS who were unfit to receive chemotherapy were enrolled on this study of gefitinib 250 mg per day given orally until disease progression. All patients had no previous chemotherapy, an Eastern Cooperative Oncology Group PS of 3, and stage IIIB/IV NSCLC. Response rate, time to disease progression, and overall survival (OS) were calculated. We evaluated the QOL of all eligible patients using the Functional Assessment of Cancer-Lung (FACT-L) questionnaire. FACT-L was used to measure the physical, social/familial, emotional, and functional well-being of the patients as well as lung cancer—specific symptoms and concerns. A Trial Outcome Index (TOI) was derived to assess the physical component of QOL. A mixed-effects linear model was used to examine the effect of potential covariates (age, race, sex, response, and duration of treatment) on the outcome of QOL scores over time. A Cox regression model was used to determine the joint effect of age, race, sex, treatment duration, and baseline TOI score on the OS of the patients.ResultsEleven out of 19 patients were evaluable for this analysis. The median age was 71.8 years (range, 60.9–73.4 years). Six patients had adenocarcinoma, and 5 patients had squamous cell carcinoma, and the median treatment duration was 63.0 days (range, 35–118 days). Grade 3/4 toxicities included fatigue, rash, and diarrhea. One patient had a partial response, 7 patients had stable disease, and 3 patients progressed. The median OS was 5.3 months (range, 2.5–22.1 months), and the median progression-free survival was 3.7 months (range, 2.1–5.8 months). Baseline TOI was weak but significantly associated with OS, with a hazard ratio (HR) of 0.92 (95% CI, 0.85–0.99; P = .03). Duration of treatment was marginally associated with survival, with an HR of 0.98 (95% CI, 0.96–1.0; P = .07). As expected, the total FACT-L score and the TOI were highly correlated (r = 0.96; P < .0001). There were no significant differences in the subscale scores, FACT-General, or the FACT-L between baseline, week 5, and week 8. Notably, an increasing trend of the TOI was observed, ranging from 33.8 at baseline to 42.0 at week 5 to 45.0 at week 8, albeit this trend was not significant. Race and age were significantly associated with the TOI. TOI scores were higher in black patients compared with white patients (P = .03) and increased with age (P = .02).ConclusionSingle-agent EGFR inhibitor gefitinib could be an active and well-tolerated therapy for patients with NSCLC with poor PS, with a trend of the TOI observed for improvement in QOL. Our results suggest that increasing age and black race had higher TOI scores and thus improved QOL status.     

Patient-physician disagreement regarding performance status is associated with worse survivorship in patients with advanced cancer

BACKGROUND.

Physician‐reported performance status (PS) is an important prognostic factor and frequently influences treatment decisions. To the authors' knowledge, the extent, prognostic importance, and predictors of disagreements in PS assessment between physicians and patients have not been adequately examined.

METHODS.

Using North Central Cancer Treatment Group (NCCTG) clinical trial data from 1987 through 1990, the authors compared PS (Eastern Cooperative Oncology Group [ECOG] and Karnofsky [KPS]) and nutrition scores reported by physicians and patients individually. Differences were analyzed using a Student t test for paired data and degree of disagreement by kappa statistic. The effect of disagreement on overall survival was determined by the Kaplan‐Meier method and Cox regression analysis. Predictors of disagreement were identified by logistic regression.

RESULTS.

In all, 1636 patients with advanced lung and colorectal cancer had a median survival of 9.8 months (95% confidence interval [95% CI], 9.4‐10.4 months). Percent disagreement between patients and physicians regarding KPS, ECOG PS, and nutrition score were 67.1%, 56.6%, and 58.0%, respectively. Physicians were more likely to rate patients better than individual patients were to rate themselves: ECOG (mean 0.91 vs 1.30; P < .0001), KPS (mean 83.3 vs 81.7; P < .0001), and nutrition score (mean 1.6 vs 2.1; P < .0001). Disagreement between patients and their physicians was associated with increased risk of death: KPS (hazards ratio [HR] of 1.16; 95% CI, 1.04‐1.30 [P = .008]) and nutrition scores (HR of 1.44; 95% CI, 1.29‐1.61 [P < .0001]) after adjustment for covariates. Patient sociodemographic factors that predict disagreement were identified.

CONCLUSIONS.

Physicians and patients frequently disagree regarding PS and nutritional status. Disagreement is associated with an increased risk of death in patients with advanced malignancies. These findings illustrate the limitations of physician‐only assessed PS. Cancer 2008. © 2008 American Cancer Society.     

Joint NCCTG and NABTC prognostic factors analysis for high-grade recurrent glioma

The purpose of this study is to determine prognostic factors in patients with high-grade recurrent glioma for 3 outcome variables (overall survival, progression-free survival [PFS], and PFS rate 6 months after study registration [PFS6]). Data from 15 North Central Cancer Treatment Group (NCCTG) trials (n = 469, 1980–2004) and 12 North American Brain Tumor Consortium (NABTC) trials (n = 596, 1998–2002) were included. Eighteen prognostic variables were considered including type of treatment center (community/academic) and initial low-grade histology (yes/no). Recursive partitioning analysis (RPA), Cox proportional hazards, and logistic regression models with bootstrap resampling were used to identify prognostic variables. Longer survival was associated with last known grade (Grade) of III, younger age, ECOG performance score (PS) of 0, shorter time from initial diagnosis (DxTime), and no baseline steroid use. Factors associated with longer PFS were Grade III and shorter DxTime. For patients without temozolomide as part of the treatment regimen, the only factor associated with better PFS6 was Grade III, although DxTime was important in RPA and PS was important in logistic regression. Grade was the most important prognostic factor for all three endpoints regardless of the statistical method used. Other important variables for one or more endpoints included age, PS, and DxTime. Neither type of treatment center nor initial low-grade histology was identified as a major predictor for any endpoint.     

Safety,Efficacy, and Patient-Reported Health-Related Quality of Life and Symptom Burden with Nivolumab in Patients with Advanced Non–Small Cell Lung Cancer,Including Patients Aged 70 Years or Older or with Poor Performance Status (CheckMate 153)

IntroductionCheckMate 153 (NCT02066636) is a phase 3B/4 study assessing nivolumab in previously treated patients with advanced NSCLC. Eligibility criteria allowed enrollment of patients with poor prognostic features of advanced age or diminished Eastern Cooperative Oncology Group performance status (ECOG PS), which are typically underrepresented in or excluded from randomized controlled trials.MethodsPatients with stage IIIB or IV NSCLC and an ECOG PS of 0 to 2 with disease progression after at least one systemic therapy received nivolumab (3 mg/kg every 2 weeks) until progression, unacceptable toxicity, or consent withdrawal. The primary end point was the incidence of grade 3 to 5 select treatment-related adverse events (TRAEs).ResultsAmong 1426 treated patients, 556 (39%) were aged 70 years or older and 128 (9%) had an ECOG PS of 2. The median treatment duration was 3.2 months. Across subgroups and the overall population, the incidences of select grade 3 to 5 TRAEs (6%–9%) and grade 3 or 4 TRAEs (12%–14%) were similar. One grade 5 TRAE was documented. The median overall survival time was comparable in the overall population (9.1 months) and patients aged 70 years or older (10.3 months) but shorter in patients with an ECOG PS of 2 (4.0 months). Patient-reported outcomes generally improved.ConclusionsData from this large predominantly community-based study, which included patients aged 70 years or older and with an ECOG PS of 2, are consistent with registrational studies. As expected, the median overall survival for patients with an ECOG PS of 2 was lower than for the overall population but comparable with historical data.     

Epoetin Alfa Improves Anemia and Anemia‐Related,Patient‐Reported Outcomes in Patients with Breast Cancer Receiving Myelotoxic Chemotherapy: Results of a European,Multicenter, Randomized,Controlled Trial

Purpose.

To evaluate the effects of epoetin alfa on patient-reported outcomes (PROs) in patients with breast cancer receiving myelotoxic chemotherapy.

Materials and Methods.

Women with hemoglobin concentrations ≤12.0 g/dl and an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0–3 were randomized 1:1 to receive epoetin alfa (10,000 IU 3 times weekly) or best standard care (BSC) during chemotherapy. The primary endpoint was the change from baseline in the total anemia subscale assessed by the Functional Assessment of Cancer Therapy–Anemia (FACT-An) questionnaire after 12 weeks of treatment. The fatigue and nonfatigue subscales from the FACT-An, the Cancer Linear Analog Scale (CLAS), hemoglobin changes, ECOG PS score, tumor response, overall survival, and safety also were evaluated.

Results.

Of 223 patients randomized, 216 constituted the modified intent-to-treat population. Percentage changes in the total anemia subscale of the FACT-An were significantly different between epoetin alfa treatment (14.2%) and BSC (−0.5%; p = .002), favoring epoetin alfa; so were changes in the FACT-An fatigue subscale (epoetin alfa, 17.5%; BSC, −0.9%; p = .003) and nonfatigue subscale (epoetin alfa, 8.8%; BSC, 0.2%; p = .008). Similar results were observed with the CLAS. Hemoglobin concentrations >12 g/dl were more common with epoetin alfa (62.0%) than with BSC (27.6%). Tumor response, ECOG PS score, 12-month survival rate, and the incidence of serious treatment-emergent adverse events were similar between groups.

Conclusion.

Early intervention with epoetin alfa was well tolerated and improved anemia-related PROs in patients with breast cancer receiving myelotoxic chemotherapy.     

Prognostic value of baseline functional status measures and geriatric screening in vulnerable older patients with metastatic colorectal cancer receiving palliative chemotherapy – The randomized NORDIC9-study

IntroductionAppropriate patient selection based on functional status is crucial when considering older adults for palliative chemotherapy. This pre-planned analysis of the randomized NORDIC9-study explored the prognostic value of four functional status measures regarding progression-free survival (PFS) and overall survival (OS) in vulnerable older patients with metastatic colorectal cancer (mCRC) receiving first-line palliative chemotherapy.Materials and methodsPatients ≥70 years of age with mCRC not candidates for standard full-dose combination chemotherapy were randomized to receive full-dose S1 or reduced-dose S1 + oxaliplatin. At baseline, functional status was assessed using ECOG performance status (ECOG PS), frailty phenotype, Geriatric 8 (G8), and Vulnerable Elderly Survey-13 (VES-13). Multivariable regression models were applied and C-statistics were estimated.ResultsIn total, 160 patients with a median age of 78 years (IQR: 76–81) were included. While in univariate analyses, ECOG PS, frailty phenotype, and VES-13 were statistically significantly associated with differences in OS between subgroups, G8 was not (HR = 1.55, 95%CI: 0.99–2.41, p = 0.050). In multivariable analyses adjusted for age, sex, body mass index, and treatment allocation, we found significant differences between subgroups for all applied tools and with C-statistics in the moderate range for ECOG PS and VES-13.Concerning PFS, statistically significant differences were observed between subgroups of ECOG PS, G8, and VES-13 both in uni- and multivariable analyses, but not for frailty phenotype.DiscussionIn this Nordic cohort of vulnerable older patients with mCRC, baseline ECOG PS, frailty phenotype, G8, and VES-13 showed prognostic value regarding overall survival, and moderate predictive value of models based on ECOG PS and VES-13 was demonstrated.     

Age-related differences in the quality of life of breast carcinoma patients after treatment.

BACKGROUND: The objective of this study was to compare the quality of life (QOL) of younger (< or =50 years) versus older (>50 years) women on recent completion of treatment of breast carcinoma. METHODS: Data reported herein were obtained from a baseline assessment of 304 breast carcinoma patients. These patients were enrolled in a multiinstitutional, randomized trial testing a psychosocial telephone counseling intervention for breast carcinoma patients immediately after treatment. The assessment was made using a self-administered (mail) questionnaire, with an overall response rate of 86%. Included in this questionnaire were standardized measures of QOL using the Functional Assessment of Cancer Therapy-Breast instrument, the Center for Epidemiologic Studies Depression Scale, and the Impact of Event Scale. RESULTS: Comparisons of baseline data analyzed according to age approximating menopausal status (< or =50 years and >50 years) indicated that younger women reported significantly greater QOL disturbance. QOL was significantly worse for younger women globally (P = 0.021), and with regard to domains of emotional well-being (P = 0.0002) and breast carcinoma specific concerns (P = 0.022). Furthermore, symptoms of depression (P = 0.041) and disease specific intrusive thoughts (P = 0.013) were significantly worse for younger women. No significant sexual dysfunction or body image differences were noted. CONCLUSIONS: Results from this analysis suggest that younger women with breast carcinoma should be considered to be at high risk for QOL disruption and significant clinical distress. Targeted interventions for this cohort are recommended.     

A population based analysis of prognostic factors in advanced biliary tract cancer

Background

Data regarding prognostic factors in advanced biliary tract cancer (BTC) remains scarce. The aim of this study was to review our institutional experience with cisplatin and gemcitabine in advanced BTC as well as to evaluate potential prognostic factors for overall survival (OS).

Material and methods

Consecutive patients with advanced BTC who initiated palliative chemotherapy with cisplatin and gemcitabine from 2009 to 2012 at the BC Cancer Agency were identified using the pharmacy database. Clinicopathologic variables and treatment outcome were retrospectively collected. Potential prognostic factors were assessed by univariate and multivariate analyses.

Results

A total of 106 patients were included in the analysis. Median OS was 8.5 months (95% CI: 6.5-10.5). On univariate analysis, poor ECOG performance status (ECOG PS) at diagnosis, primary tumor location (extra-hepatic cholangiocarcinoma, and unknown biliary cancer), and sites of advanced disease (extra-hepatic metastasis) were significantly associated with worse OS (P<0.001, 0.036 and 0.034, respectively). Age, gender, CA19-9, CEA, hemoglobin, neutrophil count, and prior stent were not significantly associated with OS. On multivariate analysis, ECOG PS 2/3 was the only predictor of poor OS (P<0.001), while primary location (P=0.089) and sites of advanced disease (P=0.079) had a non-significant trend towards prognostic significance.

Conclusions

In this population based analysis, a poorer performance status was significantly prognostic of worse OS. Although not significant in our analysis, primary tumor location and sites of advanced disease may also have prognostic relevance.     

Do age and quality of life of patients with cancer influence quality of life of the caregiver?

ObjectiveThere are significant burdens associated with providing care for loved ones with cancer. However, caregiver quality of life (QOL) is often overlooked. With the increasing number of older adults with cancer, it is important to determine whether a patient's age and QOL have any association with the caregiver's QOL. The objective of our study was to describe caregiver QOL and explore whether patient age and other psychosocial factors impact caregiver QOL.Materials and MethodsBaseline information from patients with advanced cancer undergoing radiation and their caregivers, who were enrolled in a randomized, controlled clinical trial to test the effectiveness of a structured, multidisciplinary QOL intervention, was analyzed for this study. Caregivers completed the Caregiver Quality of Life Index-Cancer (CQOLC) Scale. Both patients and caregivers completed the Linear Analogue Self-Assessment (LASA) to measure QOL, and Profile of Mood States (POMS) to measure mood states.ResultsOverall, 131 patient–caregiver pairs participated in the study. At baseline, caregivers of older adults (≥ 65 years) had higher mental (P = 0.01), emotional (P = 0.003), spiritual (P < 0.01), and social support (P = 0.03) LASA QOL scores. Caregivers of older adults also had higher baseline QOL (CQOLC, P = 0.003) and mood (POMS, P = 0.04) than caregivers of younger adults. Caregivers of patients with higher LASA QOL scores had higher overall (P = 0.02), mental (P = 0.006), physical (P = 0.02), emotional (P = 0.002), and spiritual LASA QOL scores (P = 0.047).ConclusionsCaregivers of older adults with advanced cancer demonstrated better QOL and fewer mood disturbances compared to caregivers of younger patients. When patients have good QOL, caregivers also had good QOL.     

Sarcopenia Is Associated with Quality of Life and Depression in Patients with Advanced Cancer

Background

Patients with advanced cancer often experience muscle wasting (sarcopenia), yet little is known about the characteristics associated with sarcopenia and the relationship between sarcopenia and patients’ quality of life (QOL) and mood.

Materials and Methods

As part of a randomized trial, we assessed baseline QOL (Functional Assessment of Cancer Therapy‐General [FACT‐G]) and mood (Hospital Anxiety and Depression Scale [HADS]) in patients within 8 weeks of diagnosis of incurable lung or gastrointestinal cancer, and prior to randomization. Using computed tomography scans collected as part of routine clinical care, we assessed sarcopenia at the level of the third lumbar vertebra with validated sex‐specific cutoffs. We used logistic regression to explore characteristics associated with presence of sarcopenia. To examine associations between sarcopenia, QOL and mood, we used linear regression, adjusted for patients’ age, sex, marital status, education, and cancer type.

Results

Of 237 participants (mean age = 64.41 ± 10.93 years), the majority were male (54.0%) and married (70.5%) and had lung cancer (56.5%). Over half had sarcopenia (55.3%). Older age (odds ratio [OR] = 1.05, p = .002) and education beyond high school (OR = 1.95, p = .047) were associated with greater likelihood of having sarcopenia, while female sex (OR = 0.25, p < .001) and higher body mass index (OR = 0.79, p < .001) correlated with lower likelihood of sarcopenia. Sarcopenia was associated with worse QOL (FACT‐G: B = ?4.26, p = .048) and greater depression symptoms (HADS‐depression: B = ?1.56, p = .005).

Conclusion

Sarcopenia was highly prevalent among patients with newly diagnosed, incurable cancer. The associations of sarcopenia with worse QOL and depression symptoms highlight the need to address the issue of sarcopenia early in the course of illness.

Implications for Practice

This study found that sarcopenia, assessed using computed tomography scans acquired as part of routine clinical care, is highly prevalent in patients with newly diagnosed, incurable cancer. Notably, patients with sarcopenia reported worse quality of life and greater depression symptoms than those without sarcopenia. These findings highlight the importance of addressing muscle loss early in the course of illness among patients with incurable cancer. In the future, investigators should expand upon these findings to develop strategies for assessing and treating sarcopenia while striving to enhance the quality of life and mood outcomes of patients with advanced cancer.     

Patient-Reported Outcomes From Patients Receiving Immunotherapy or Chemoimmunotherapy for Metastatic Non–Small-Cell Lung Cancer in Clinical Practice

IntroductionImmunotherapy and chemoimmunotherapy clinical trials for metastatic non–small-cell lung cancer (mNSCLC) have generally excluded patients with poor performance status (PS) and have utilized patient-reported measures that could miss some symptoms associated with immunotherapy. The goals of this study were to describe quality of life and symptom burden among mNSCLC patients receiving immunotherapy in clinical practice, and to examine burden by Eastern Cooperative Oncology Group performance status (ECOG PS) and age.Patients and MethodsBetween 2017 and 2018, mNSCLC patients receiving immuno/chemoimmunotherapy at an academic medical center completed the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) and the National Cancer Institute Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Univariate and bivariate analyses described EORTC-QLQ-C30 subscales and the proportion reporting at least moderate PRO-CTCAE symptoms, and compared scores by ECOG PS (0/1 vs. 2/3) and age (< 70 vs. ≥ 70 years).ResultsSixty patients (60% female; 75% < 70 years old; 68% ECOG PS 0/1; 57% receiving single-agent immunotherapy) participated. The mean EORTC-QLQ-C30 global health score was 62.6; EORTC symptoms were highest for fatigue, insomnia, dyspnea, and financial concerns (all > 30). Global health and pain were worse in ECOG PS 2/3 patients. For PRO-CTCAE, 20% to 40% reported at least moderate gastrointestinal, respiratory, dermatologic, arthralgia, or myalgia symptoms. The PRO-CTCAE pain score was higher among ECOG PS 2/3 patients.ConclusionIn clinical practice, global health was largely comparable to published clinical trials, but PRO-CTCAE items indicated a higher symptom prevalence. Closer monitoring of symptoms is warranted in ECOG PS 2/3 patients.