Prostate cancer screening and shared decision-making preferences among African-American members of the Prince Hall Masons

Objectives: Shared decision making (SDM) is recommended as one method to assist men in making an informed decision about prostate cancer screening (PCS). SDM preferences for PCS have not been evaluated among African‐American (AA) men. Given AA men's increased risk and the uncertainty surrounding screening, it is critical to determine how to assist AA men in making an informed decision. We assessed the extent to which a sample of AA men wished to engage in SDM regarding PCS and the demographic and psychological characteristics associated with SDM preferences. Methods: Participants completed a telephone interview that covered demographic and medical information, SDM preferences, PCS knowledge, decisional conflict, and satisfaction with previous screening decisions. Subjects included 286 AA men aged 40–70, who were members of a Masonic organization. Results: Fifty‐seven percent preferred SDM, 36% preferred to make their own decision, and 7% wanted their doctor to decide. A higher level of education and older age were associated with preferring SDM (p<0.05), while men with greater PCS knowledge were more likely to prefer to make the decision independently (p<0.05). Conclusions: Results suggest that physicians need to be prepared to discuss PCS with their patients. Further, more attention may be needed to engage younger, less educated, and less knowledgeable men as they may be less likely to discuss PCS. This understanding of AA men's preferences for PCS decisions helps to clarify the issues that health professionals need to consider when attempting to assist AA men in making a PCS decision. Copyright © 2008 John Wiley & Sons, Ltd.     

Who makes the decision regarding the treatment of clinically localized prostate cancer–the patient or physician?

BACKGROUND:

The current study examined how patients' sociodemographic, cancer‐related, and subjective affective factors impacted their role in treatment decision‐making.

METHODS:

The patient sample (N = 788) was taken from a prospective follow‐up study of a population‐based cohort. Participants included 343 African American and 445 Caucasian‐American patients with clinically localized prostate cancer. Multinomial logistic regression was used to investigate relations between the explanatory variables and the nominal 3‐level decision‐making variable: patient‐only, patient‐physician shared, and physician‐only.

RESULTS:

Approximately 41% of patients reported patient‐only decision‐making, 45% reported shared decision‐making, and 13% reported physician‐only decision‐making. The odds of patient‐only over physician‐only decision‐making were greater for younger men (vs those aged ≥ 65 years) (odds ratio [OR], 1.68; 95% confidence interval [95% CI], 1.03‐2.74), and were less for men with high (vs low) cancer aggressiveness (OR,0.29; 95% CI, 0.15‐0.55). The odds of shared over physician‐only decision‐making were less for men with high (vs low) cancer aggressiveness (OR, 0.40; 95% CI, 0.22‐0.73). Greater odds of patient‐only and shared decision‐making also were found to be associated with greater concerns about the physical impact of treatment and having enough time for decision‐making and lower scores of receiving advice from others.

CONCLUSIONS:

The findings of the current study indicate that, to facilitate a more patient‐oriented decision‐making process regarding treatment in those with clinically localized prostate cancer, clinicians need to tailor their interventions according to patient age and cancer aggressiveness, help reduce patient concerns and misconceptions regarding the physical impact of treatments, allow sufficient time for patients to consider treatment options, and assist patients in balancing advice and information received from different sources. Cancer 2013. © 2012 American Cancer Society.     

Financial Burden Among Patients With Lung Cancer in a Publically Funded Health Care System

IntroductionFinancial distress has been established as a clinically relevant patient-reported outcome associated with worse mortality and quality of life. Our goal was to define factors associated with financial burden (FB) in a public health care system.Materials and MethodsPatients with advanced lung cancer were recruited from outpatient clinics at the Princess Margaret Cancer Centre (Toronto, Canada). FB was measured with the validated Comprehensive Score for Financial Toxicity (COST) instrument, a 12-item survey scored from 0 to 44, with lower scores reflecting worse financial well-being. Data on patient and treatment characteristics, total out-of-pocket costs (OOP), and private insurance coverage were collected. Multivariable logistic regression models were fit for COST score and each variable, to determine factors associated with greater FB (COST < 21).ResultsOf 251 patients approached, 200 (80%) participated. The median age of the cohort was 65 years; 56% were female. The median total OOP ranged between $1000 and $5000 CAD. The median COST score was 21 (range, 0-44). FB was associated with age, with patients < 65 years reporting greater FB than older patients (COST, 18.0 vs. 24.0; P < .0001). In multivariable logistic regression analysis, younger age was associated with greater FB, when adjusting for income, employment status, OOP, and private insurance coverage (odds ratio, 3.6; 95% confidence interval, 1.5-9.1; P < .0001).ConclusionAge is significantly associated with FB in the Canadian (Ontario) public health care system, with younger patients with lung cancer reporting greater financial distress. This study highlights priority patient populations where FB should be routinely assessed and appropriate resources for support offered.     

Assessing the Financial Toxicity of Radiation Oncology Patients Using the Validated Comprehensive Score for Financial Toxicity as a Patient-Reported Outcome

PurposeThe financial burden of cancer care may significantly affect patient quality of life and clinical outcomes. However, the financial effect of radiation therapy on patients remains difficult to characterize, in part owing to the lack of standardized methods to measure patient distress related to treatment costs. Here, we assessed financial burden in the radiation oncology population by applying the Comprehensive Score for Financial Toxicity (COST), a patient-reported outcome measure, which has been validated in medical oncology patients. Methods and MaterialsConsecutive patients from a single academic radiation oncology clinic were recruited. Participants completed the 11-item COST-Functional Assessment of Chronic Illness Therapy questionnaire, with total possible scores ranging from 0 to 44. Scores were collected along with data regarding patient demographics, insurance, diagnosis, and treatment. Univariate and multivariate analyses were performed to identify factors associated with higher financial burden as measured by COST.ResultsA total of 167 patients completed the COST questionnaire. Lower COST scores indicated higher financial toxicity. The population’s mean COST score was 21.9 (95% confidence interval, 20.5-23.3). Fifteen percent of participants reported grade 2 to 3 COST toxicity, corresponding to a moderate or severe effect on quality of life. Use of concurrent or previous systemic therapy was significantly associated with lower COST scores on univariate analysis (P = .03), but not significant on multivariate analysis. A subset analysis of posttreatment follow-up patients identified rural residence and recent completion of radiation therapy as significant correlates of worse COST scores on univariate analysis, and rural residence remained independently associated on multivariate analysis (P = .017).Conclusions COST effectively identified a significant number of radiation oncology patients experiencing financial toxicity, indicating its prevalence in this population. A correlate of financial toxicity in this population is the use of systemic therapy. Of those who have completed radiation therapy, rural residence was independently associated with worse financial toxicity.     

Use of implicit persuasion in decision making about adjuvant cancer treatment: A potential barrier to shared decision making

BackgroundShared decision making (SDM) is widely advocated, especially for preference-sensitive decisions like those on adjuvant treatment for early-stage cancer. Here, decision making involves a subjective trade-off between benefits and side-effects, and therefore, patients' informed preferences should be taken into account. If clinicians consciously or unconsciously steer patients towards the option they think is in their patients' best interest (i.e. implicit persuasion), they may be unwittingly subverting their own efforts to implement SDM. We assessed the frequency of use of implicit persuasion during consultations and whether the use of implicit persuasion was associated with expected treatment benefit and/or decision making.MethodsObservational study design in which consecutive consultations about adjuvant systemic therapy with stage I–II breast cancer patients treated at oncology outpatient clinics of general teaching hospitals and university medical centres were audiotaped, transcribed and coded by two researchers independently.ResultsIn total, 105 patients (median age = 59; range: 35–87 years) were included. A median of five (range: 2–10) implicitly persuasive behaviours were employed per consultation. The number of behaviours used did not differ by disease stage (P = 0.07), but did differ by treatment option presented (P = 0.002) and nodal status (P = 0.01). About 50% of patients with stage I or node-negative disease were steered towards undergoing chemotherapy, whereas 96% of patients were steered towards undergoing endocrine therapy, irrespective of expected treatment benefit. Decisions were less often postponed if more implicit persuasion was used (P = 0.03).InterpretationOncologists frequently use implicit persuasion, steering patients towards the treatment option that they think is in their patients' best interest. Expected treatment benefit does not always seem to be the driving force behind implicit persuasion. Awareness of one's use of these steering behaviours during decision making is a first step to help overcome the performance gap between advocating and implementing SDM.     

Patients’ preference for radiotherapy fractionation schedule in the palliation of symptomatic unresectable lung cancer†

The palliative radiotherapeutic management of unresectable non‐small‐cell lung cancer is controversial, with various fractionation (Fx) schedules available. We aimed to determine patient’s choice of Fx schedule after involvement in a decision‐making process using a decision board. A decision board outlining the various advantages and disadvantages apparent in the Medical Research Council study of Fx schedules (17 Gy in two fractions vs 39 Gy in 13 fractions) was discussed with patients who met Medical Research Council eligibility criteria. Patients were then asked to indicate their preferred Fx schedules, reasons and their level of satisfaction with being involved in the decision‐making process. Radiation oncologists (RO) could prescribe radiotherapy schedules irrespective of patients’ preferences. Of 92 patients enrolled, 55% chose the longer schedule. English‐speaking patients were significantly more likely to choose the longer schedule (P = 0.02, 95% confidence interval: 1.2–7.6). Longer Fx was chosen because of longer survival (90%) and better local control (12%). Shorter Fx was chosen for shorter overall treatment duration (80%), cost (61%) and better symptom control (20%). In all, 56% of patients choosing the shorter schedule had their treatment altered by the treating RO, whereas only 4% of patients choosing longer Fx had their treatment altered (P < 0.001). Despite this, all (100%) patients were satisfied with being involved in the decision‐making process. The decision board was useful in aiding decision‐making, with both Fx schedules being acceptable to patients. Interestingly, despite the longer average survival associated with longer Fx, nearly half of the patients believed that this was not as important as a shorter duration of treatment and lower cost. Despite patients’ preferences, there were significant alterations of preferred schedules because of RO’s own biases.     

Financial Toxicity in Women With Breast Cancer Receiving Radiation Therapy: Final Results of a Prospective Observational Study

PurposeWe sought to quantify financial toxicity (FT) present in a prospective cohort of women with breast cancer (BC) receiving radiation therapy (RT), identify predictors of FT, correlate FT with health-related quality of life (QoL), and determine whether duration of RT is associated with FT.Methods and MaterialsConsecutive patients with stage I-III BC completed Functional Assessment of Cancer Therapy-G7 (FACT-G7), a tailored FT questionnaire, and Comprehensive Score for Financial Toxicity (COST) scoring within 1 month of RT completion. Lower scores on FACT-G7 (range, 0-28) and COST (range, 0-44) indicate worse QoL and FT. Group comparisons were performed with a 2-sample t test and χ² tests for continuous and categorical variables, respectively. Pearson correlation was used to associate COST with FACT-G7. Linear and multiple regression were used to evaluate predictors of COST.ResultsOne hundred eight enrolled patients were eligible for analysis with completed COST scores, including 56, 42, and 10 patients treated with long-, intermediate-, and short-course RT. Mean COST score was 28.6 and mean FACT-G7 was 18.4. Among patients treated with intermediate- and long-course RT (n = 98), marital status (higher COST associated with married status relative to other), medication cost (higher COST for no significant medication costs relative to significant medication costs), employment type (lower COST associated with disabled status or unemployed, higher COST with retired status relative to working), and surgery type (higher COST for lumpectomy relative to mastectomy) were significantly associated with COST score by multivariable analysis (all P values < .05). RT length group was not associated with COST (P = .79). COST and FACT-G7 were strongly correlated for the overall cohort (P < .0001).ConclusionsIn this prospective study of women with BC receiving RT, distinct factors including surgery type were significantly associated with FT. FT was strongly correlated with health-related QoL. Increased characterization of the relationship between FT and health-related QoL for women with BC receiving RT and defining clinical predictors of FT may help guide future studies investigating optimal targeted interventions for patients with BC at high risk for FT.     

Implementing and evaluating shared decision making in oncology practice

Answer questions and earn CME/CNE Engaging individuals with cancer in decision making about their treatments has received increased attention; shared decision making (SDM) has become a hallmark of patient‐centered care. Although physicians indicate substantial interest in SDM, implementing SDM in cancer care is often complex; high levels of uncertainty may exist, and health care providers must help patients understand the potential risks versus benefits of different treatment options. However, patients who are more engaged in their health care decision making are more likely to experience confidence in and satisfaction with treatment decisions and increased trust in their providers. To implement SDM in oncology practice, physicians and other health care providers need to understand the components of SDM and the approaches to supporting and facilitating this process as part of cancer care. This review summarizes recent information regarding patient and physician factors that influence SDM for cancer care, outcomes resulting from successful SDM, and strategies for implementing SDM in oncology practice. We present a conceptual model illustrating the components of SDM in cancer care and provide recommendations for facilitating SDM in oncology practice. CA Cancer J Clin 2014;64:377–388. © 2014 American Cancer Society .     

Augmenting advance care planning in poor prognosis cancer with a video decision aid: a preintervention-postintervention study

BACKGROUND:

The authors tested whether an educational video on the goals of care in advanced cancer (life‐prolonging care, basic care, or comfort care) helped patients understand these goals and had an impact on their preferences for resuscitation.

METHODS:

A survey of 80 patients with advanced cancer was conducted before and after they viewed an educational video. The outcomes of interest included changes in goals of care preference and knowledge and consistency of preferences with code status.

RESULTS:

Before viewing the video, 10 patients (13%) preferred life‐prolonging care, 24 patients (30%) preferred basic care, 29 patients (36%) preferred comfort care, and 17 patients (21%) were unsure. Preferences did not change after the video, when 9 patients (11%) chose life‐prolonging care, 28 patients (35%) chose basic care, 29 patients (36%) chose comfort care, and, 14 patients (18%) were unsure (P = .28). Compared with baseline, after the video presentation, more patients did not want cardiopulmonary resuscitation (CPR) (71% vs 62%; P = .03) or ventilation (80% vs 67%; P = .008). Knowledge about goals of care and likelihood of resuscitation increased after the video (P < .001). Of the patients who did not want CPR or ventilation after the video augmentation, only 4 patients (5%) had a documented do‐not‐resuscitate order in their medical record (kappa statistic, ?0.01; 95% confidence interval, ?0.06 to 0.04). Acceptability of the video was high.

CONCLUSIONS:

Patients with advanced cancer did not change care preferences after viewing the video, but fewer wanted CPR or ventilation. Documented code status was inconsistent with patient preferences. Patients were more knowledgeable after the video, reported that the video was acceptable, and said they would recommend it to others. The current results indicated that this type of video may enable patients to visualize “goals of care,” enriching patient understanding of worsening health states and better informing decision making. Cancer 2012. © 2012 American Cancer Society.     

Decision Regret among Patients with Early-stage Lung Cancer Undergoing Radiation Therapy or Surgical Resection

AimsClinical equipoise exists regarding early-stage lung cancer treatment among patients as trials comparing stereotactic body radiation therapy (SBRT) and surgical resection are unavailable. Given the potential differences in treatment effectiveness and side-effects, we sought to determine the associations between treatment type, decision regret and depression.Materials and methodsA multicentre, prospective study of patients with stage IA–IIA non-small cell lung cancer (NSCLC) with planned treatment with SBRT or surgical resection was conducted. Decision regret and depression were measured using the Decision Regret Scale (DRS) and Patient Health Questionnaire-4 (PHQ-4) at 3, 6 and 12 months post-treatment, respectively. Mixed linear regression modelling examined associations between treatment and decision regret adjusting for patient sociodemographics.ResultsAmong 211 study participants with early-stage lung cancer, 128 (61%) patients received SBRT and 83 (39%) received surgical resection. The mean age was 73 years (standard deviation = 8); 57% were female; 79% were White non-Hispanic. In the entire cohort at 3 months post-treatment, 72 (34%) and 57 (27%) patients had mild and severe decision regret, respectively. Among patients who received SBRT or surgery, 71% and 46% of patients experienced at least mild decision regret at 3 months, respectively. DRS scores increased at 6 months and decreased slightly at 12 months of follow-up in both groups. Higher DRS scores were associated with SBRT treatment (adjusted mean difference = 4.18, 95% confidence interval 0.82 to 7.54) and depression (adjusted mean difference = 3.49, 95% confidence interval 0.52 to 6.47). Neither patient satisfaction with their provider nor decision-making role concordance was associated with DRS scores.ConclusionsMost early-stage lung cancer patients experienced at least mild decision regret, which was associated with SBRT treatment and depression symptoms. Findings suggest patients with early-stage lung cancer may not be receiving optimal treatment decision-making support. Therefore, opportunities for improved patient–clinician communication probably exist.     

A Phase II Study of Pembrolizumab in Combination With Palliative Radiotherapy for Hormone Receptor-positive Metastatic Breast Cancer

BackgroundThe purpose of this study was to investigate whether combining pembrolizumab with palliative radiation therapy (RT) improves outcomes in patients with hormone receptor-positive (HR⁺) metastatic breast cancer (MBC).Patients and MethodsEligible patients had HR⁺/human epidermal growth factor receptor 2-negative MBC; were candidates for RT to ≥ 1 bone, soft tissue, or lymph node lesion; and had ≥ 1 lesion outside the RT field. Patients received 200 mg pembrolizumab intravenously 2 to 7 days prior to RT and on day 1 of repeating 21-day cycles. RT was delivered to a previously unirradiated area in 5 treatments each of 4 Gy. The primary endpoint was objective response rate. The study used a 2-stage design: 8 women were enrolled into the first stage, and if at least 1 of 8 patients experienced an objective response, 19 more would be enrolled. Secondary endpoints included progression-free survival, overall survival, and safety. Exploratory endpoints included association of overall response rate with programmed death-ligand 1 status and tumor-infiltrating lymphocytes.ResultsEight patients were enrolled in stage 1. The median age was 59 years, and the median prior lines of chemotherapy for metastatic disease was 2. There were no objective responses, and the study was closed to further accrual. The median progression-free survival was 1.4 months (95% confidence interval, 0.4-2.1 months), and the median overall survival was 2.9 months (95% confidence interval, 0.9-3.6 months). All-cause adverse events occurred in 87.5% of patients, including just 1 grade 3 event (elevation of aspartate aminotransferase).ConclusionsRT combined with pembrolizumab did not produce an objective response in patients with heavily pre-treated HR⁺ MBC. Future studies should consider alternative radiation dosing and fractionation in patients with less heavily pre-treated HR⁺ MBC.     

Phase II Trial of Fulvestrant With Metronomic Capecitabine for Postmenopausal Women With Hormone Receptor-Positive,HER2-Negative Metastatic Breast Cancer

BackgroundIn this phase II study, we explored efficacy and toxicity of combined endocrine and low-dose metronomic chemotherapy therapy consisting of fulvestrant and capecitabine in estrogen and/or progesterone receptor-positive, HER2-negative MBC.Patients and MethodsPatients with ≤ 1 previous hormonal treatment in the metastatic setting received an injection fulvestrant loading dose 500 mg on day 1, 250 mg on days 15 and 29 followed by 250 mg every 28 days along with continuous oral capecitabine in divided doses. The total fixed daily dose of capecitabine was either 1500 mg or 2000 mg, depending on the patient’s weight (< 80 kg vs. ≥ 80 kg). Primary end points were PFS and TTP. Toxicity was assessed by continuous evaluations of treatment-emergent adverse events (AEs) and changes from baseline in laboratory values.ResultsForty-one women, with a mean age of 64.5 years, were enrolled. Patients completed a median of 11 monthly treatment cycles. Median PFS was 14.98 months (95% confidence interval [CI], 7.26-upper limit [UL] not estimated) and median TTP was 26.94 months (95% CI, 7.26-UL not estimated). Median overall survival was 28.65 months (95% CI, 23.95-UL not estimated). Treatment was well tolerated with < 10% Grade 3 palmar-plantar erythrodysesthesia. Overall, the most frequent AEs were palmar-plantar erythrodysesthesia, fatigue, and nausea.ConclusionFulvestrant with metronomic capecitabine demonstrates substantial activity in hormone receptor-positive MBC and is well tolerated. Combined chemoendocrine approaches should be further explored considering the low toxicity of the combination with meaningful TTP.     

Participation and satisfaction with surgical treatment decision-making in breast cancer among Chinese women

Purpose. To report Chinese women's preferred and perceived participation in breast cancer treatment decision making (TDM), describe influences on women's participation preference and participation congruence (PC) (correspondence between preferred and actual amount of participation in TDM), and explore subsequent satisfaction with TDM. Patients and methods. Of 172/211 eligible and available Chinese women recently undergoing breast cancer surgery at one of six Hong Kong government hospitals 154 (89.5%) were recruited. Within 12 days after surgery, women provided interview information on preferred and perceived TDM participation, satisfaction with TDM consultation, difficulties in TDM, and medical and demographic information. Results. Half (55%) reported a treatment choice: 33% wanted the choice to be their own, 59% wanted to share and 8% wanted to delegate the decision. Only age predicted participation preference with older women preferring a more passive role. Eighty percent of women participated as much as, 13% more than and 6% less than desired. Adjusted for age, women reporting PC had fewer difficulties in TDM ( = 0.21, p = 0.009) than women not reporting PC, while over-involved women had more doubts about their choice ( = –0.23, p = 0.005). PC was associated with being offered a treatment option (² = 15.59, p < 0.001) and surgeons expressing a surgical preference (² = 6.63, p = 0.036). Satisfaction was unrelated to PC. Conclusion. Most Chinese women want shared TDM and to know their surgeon's treatment preference. Over-involved women are at greater risk of difficulties and doubts in TDM and under-involved women perceive a lack of time and information to make their decision.     

Decision‐making preferences and information needs among Greek breast cancer patients

Objectives: We aimed at assessing Greek breast cancer patients' preferences for participation in treatment decision making and their information needs. Methods: In a cross‐sectional study, 329 breast cancer patients were administered at the Control Preferences Scale, a card‐sort measurement designed to elicit preferences for participation in decision making. Information needs were assessed with Cassileth's Information Styles Questionnaire. Results: The majority of patients (71.1%) preferred to play a passive role in treatment decision making, with most of them wanting to delegate responsibility of the decision completely to their doctor (45.3%). A collaborative role was preferred by 24%, whereas only 4.6% chose an active role. Most women expressed a general desire for as much information as possible about their illness (62.6%), but a substantial proportion (37.4%) did not want detailed information; instead, they wished to avoid awareness of bad news. Women who desired less informational details and preferred a passive role requested less frequently a mammography (p<0.001) and/or Pap test (p<0.0005) prediagnostically. Conclusions: This study's findings showed that the proportion of patients who wanted to play a passive role in decision making is the highest reported compared to similar studies from other countries, indicating the impact of the dominating paternalistic model of the doctor–patient relationship in the Greek medical encounter. The association of desired information details and decision‐making preferences with screening for cancer procedures prediagnostically highlights the significance of providing the patients with the appropriate information and the choices available for their treatment. Copyright © 2010 John Wiley & Sons, Ltd.     

Concordance between patients' desired and actual decision-making roles in breast cancer care

This study explored breast cancer patients' preferences and experiences for participation in treatment decision making as well as the concordance between patients' actual and desired decision making. The interplay between depression, anxiety and decision-making preferences was also examined.A consecutive sample of primary breast cancer patients was recruited within a week of either surgery or the beginning of neo-adjuvant chemotherapy in two breast cancer centres in Germany. Women were asked to complete a self-explanatory questionnaire.Most patients (40.2%) of the 137 participants preferred the physician to make the treatment decision. A total of 63.4% were able to fulfil their preferred decision-making role. Breast cancer patients who wanted the physician to make the decision and patients who wanted to make the decision on their own were more likely to have their preferences met than patients who wished to share the decision (p < 0.01). Availability of treatment choice and the level of depression influenced the preferred decision-making preference.Limited concordance between desired and actual decision making of patients with collaborative decision-making preferences suggests the need for better communication and physician training on shared decision making.     

Treatment preferences and involvement in treatment decision making of patients with endometrial cancer and clinicians

Background:

Vaginal brachytherapy (VBT) in high–intermediate-risk endometrial cancer (EC) provides a significant reduction in the risk of local cancer recurrence, but without survival benefit and with increased mucosal atrophy. Five-year local control is estimated to be similar for VBT and a watchful waiting policy (WWP), in which patients receive VBT combined with external radiation in case of a recurrence. Our aim was to assess treatment preferences of EC patients and clinicians regarding VBT and WWP, and to evaluate their preferred and perceived involvement in treatment decision making.

Methods:

Interviews were held with 95 treated EC patients. The treatment trade-off method was used to assess the minimally desired benefit from VBT in local control. Patients'' preferred and perceived involvement in decision making were assessed using a questionnaire. Seventy-seven clinicians completed a questionnaire assessing their minimally desired benefit and preferred involvement in decision making.

Results:

Minimally desired benefit of VBT was significantly lower for patients than for clinicians (median=0 vs 8%, P<0.001), for irradiated than for non-irradiated patients (median=0 vs 6.5%, P<0.001), and for radiation oncologists than for gynaecologists (median=4 vs 13%, P<0.001). Substantial variation existed within the groups of patients and clinicians. Participants preferred the patient and clinician to share in the decision about VBT. However, irradiated patients indicated low perceived involvement in actual treatment decision making.

Conclusions:

We found variations between and within patients and clinicians in minimally desired benefit from VBT. However, the recurrence risk at which patients preferred VBT was low. Our results showed that patients consider active participation in decision making essential.     

Maintenance of clinical efficacy after dose reduction of ixabepilone plus capecitabine in patients with anthracycline- and taxane-resistant metastatic breast cancer: a retrospective analysis of pooled data from 2 phase III randomized clinical trials

BackgroundThis retrospective analysis aimed to determine whether early dose reduction impacts the efficacy of ixabepilone plus capecitabine in women with metastatic breast cancer (MBC).Patients and MethodsIn 2 phase III trials, patients (N = 1973) with anthracycline/taxane–pretreated MBC were randomized to receive ixabepilone 40 mg/m² on day 1 plus capecitabine 1000 mg/m² twice daily (BID) on days 1 to 14 or single-agent capecitabine 1250 mg/m² BID on days 1 to 14 of a 3-week course. Because of the similar design and populations, data from trials were pooled to evaluate efficacy of the combination regimen among women who did or did not undergo ixabepilone dose reduction during the first 4 courses. To adjust for bias resulting from selecting patients with inherently better outcome based on longer treatment durations, these analyses were restricted to patients who received ≥ 4 courses of ixabepilone.ResultsThe pooled cohort included 566 patients with measurable disease who were evaluable for efficacy. Patients who had early dose reduction showed similar objective response rates (ORRs) and progression-free survival (PFS) as did those with no/late dose reduction. ORRs were 62.6% (95% confidence interval [CI], 55.8%-69.0%) and 55.3% (95% CI, 49.9%-60.6%), respectively; median PFS was 7.2 months (95% CI, 6.6-8.0) and 7.0 months (95% CI, 6.5-7.5), respectively (hazard ratio = 0.98; 95% CI, 0.83-1.17).ConclusionThese data suggest that early ixabepilone dose reduction did not affect the overall efficacy of ixabepilone plus capecitabine in patients with MBC who received ≥ 4 courses of treatment. By making appropriate dose reductions, ixabepilone-related toxicities can be minimized while maintaining clinical efficacy.     

Metronomic chemotherapy combined with bevacizumab and erlotinib in patients with metastatic HER2-negative breast cancer: clinical and biological activity

BackgroundThe object of this study was to evaluate the safety and efficacy of metronomic chemotherapy in combination with bevacizumab and erlotinib in patients with HER2-negative (HER2^?) metastatic breast cancer (MBC) and poor hormone receptor expression.Patients and MethodsPatients with untreated MBC were candidates to receive metronomic oral capecitabine (500 mg thrice daily) and cyclophosphamide (50 mg daily) plus bevacizumab (15 mg/kg every 3 weeks) and erlotinib (100 mg daily).ResultsOf 24 patients assessable for response, we observed 1 complete response (CR, 4%), 14 partial responses (58%), 5 patients with stable disease greater than 9 weeks' duration (SD, 21%), and 1 patient (4%) with early progression of disease. The overall clinical benefit (CB) (CR + partial response + SD > 24 weeks) was 75% (95% confidence interval [CI], 53%-90%). Median time to progression was 43 weeks (95% CI, 21-69). Patients with low levels of circulating endothelial progenitors (CEPs) at baseline had a significantly improved progression-free survival (PFS). Toxicity was generally mild. Grade 3 toxicity included diarrhea (n = 1), thrombosis (n = 1), and hypertension (n = 2). Grade 2 adverse events included diarrhea (n = 5), hand-foot syndrome (n = 13), and hypertension (n = 4).ConclusionTreatment with metronomic chemotherapy in combination with bevacizumab and erlotinib was effective in HER2^?, estrogen receptor (ER)- and progesterone receptor (PR)-poor advanced breast cancer.     

The role of surgery for locally recurrent and second recurrent rectal cancer with metastatic disease

BackgroundThe role of surgery for locally recurrent rectal cancer (LRRC) with resectable distant metastases or second LRRC remains unclear. This study aimed to clarify the influence of synchronous distant metastases (SDMs), a history of distant metastasis resection (HDMR), and a second LRRC on the outcome.MethodsThe long-term outcomes of 70 surgically treated patients with LRRC between 2006 and 2018 were compared by SDM (n = 10), HDMR (n = 17), and second LRRC (n = 7).ResultsAmong the 10 patients with SDM, 4 patients underwent simultaneous resection, whereas the other 6 underwent staged resection with distant first approach. Recurrence developed in 9 patients, of which 2 patients with liver re-resection achieved long-term survival without cancer. The patients with and without SDM had equivalent 5-year overall survival rate (40.5% vs. 53.3%, p = 0.519); however, patients with SDM had a worse 3-year recurrence-free survival rate than those without SDM (10.0% vs. 37.5%, p = 0.031). Multivariate analysis showed that primary non-sphincter-preserving surgery, second LRRC, and R1 resection were independent risk factors for overall survival. Similarly, primary non-sphincter-preserving surgery, second LRRC, SDM, and R1 resection were risk factors for recurrence-free survival.ConclusionsPatients with SDM might still be suitable to undergo salvage surgery and achieve favourable overall survival. Distant metastasectomy should be performed first, followed by a sufficient interval to avoid unnecessary LRRC resection in uncurable patients. An HDMR should not be taken into consideration when making surgical plans. Surgical indication of second LRRC should be strict, especially in referred patients.     

Features Associated With Long-Term Survival in Patients With Metastatic Breast Cancer

BackgroundOf women diagnosed with metastatic breast cancer (MBC), 20% to 30% survive ≥5 years. We evaluated data from a large breast cancer program to identify features associated with MBC survival.Patients and MethodsWomen diagnosed with MBC in or after 1999 were included. Long-term MBC survival was defined as ≥5 years from date of MBC diagnosis (n = 122), short-term MBC survival as ≤2 years (n = 191). Differences were assessed using t tests, Wilcoxon–Mann–Whitney tests, χ², and Fisher exact tests. Odds ratios (ORs) were calculated using multivariate logistic regression models.ResultsLong-term survivors were significantly (P < .05) younger, premenopausal, partnered, had estrogen receptor (ER)-positive, progesterone receptor-positive, and HER2-positive disease, lower Charlson Comorbidity Index, lower rates of visceral metastases, and higher household income. After adjustment for potential confounders, de novo MBC, premenopausal status, ER-positive status, and HER2-positive status remained significantly positively associated with long-term survival (respectively: OR, 2.68 [95% confidence interval (CI), 1.48-4.88]; OR, 1.96 [95% CI, 1.02-3.79]; OR, 3.74 [95% CI, 1.72-8.14]; OR, 2.88 [95% CI, 1.61-5.14]). Triple-negative status, visceral with bone metastases, and brain metastases remained negatively associated with long-term survival (respectively: OR, 0.12 [95% CI, 0.05-0.29]; OR, 0.18 [95% CI, 0.07-0.47]; OR, 0.16 [95% CI, 0.04-0.60]). Partner status and household income were significant in univariate but not multivariate analyses.ConclusionDiagnosis of de novo MBC, premenopausal status, ER-positive status, and HER2-positive status were positively associated whereas triple-negative status, brain metastases, and visceral with bone metastases were inversely associated with long-term survival. These findings can be applied to better prognosticate survival for MBC patients.