Participation of patients 65 years of age or older in cancer clinical trials.

PURPOSE: Although 61% of new cases of cancer occur among the elderly, recent studies indicate that the elderly comprise only 25% of participants in cancer clinical trials. Further investigation into the reasons for low elderly participation is warranted. Our objective was to evaluate the participation of the elderly in clinical trials sponsored by the National Cancer Institute (NCI) and assess the impact of protocol exclusion criteria on elderly participation. PATIENTS AND METHODS: We conducted a retrospective analysis using NCI data, analyzing patient and trial characteristics for 59,300 patients enrolled onto 495 NCI-sponsored, cooperative group trials, active from 1997 through 2000. Our main outcome measure was the proportion of elderly patients enrolled onto cancer clinical trials compared with the proportion of incident cancer patients who are elderly. RESULTS: Overall, 32% of participants in phase II and III clinical trials were elderly, compared with 61% of patients with incident cancers in the United States who are elderly. The degree of underrepresentation was more pronounced in trials for early-stage cancers than in trials for late-stage cancers (P <.001). Furthermore, protocol exclusion criteria on the basis of organ-system abnormalities and functional status limitations were associated with lower elderly participation. We estimate that if protocol exclusions were relaxed, elderly participation in cancer trials would be 60%. CONCLUSION: The elderly are underrepresented in cancer clinical trials relative to their disease burden. Older patients are more likely to have medical histories that make them ineligible for clinical trials because of protocol exclusions. Insurance coverage for clinical trials is one step toward improvement of elderly access to clinical trials. Without a change in study design or requirements, this step may not be sufficient.     

Non-Hodgkin's lymphoma in patients 70 years of age or older: factors associated with survival

The incidence of non-Hodgkin's lymphoma (NHL) has increased dramatically especially in persons over 60 years of age. We reviewed our experience in patients with NHL who were 70 years of age or older and seen between 1992 and 1998 in an effort to find any unique risk factors in this age group. There were 64 patients. Twenty-five had indolent disease and 38 had aggressive disease. The majority of patients with indolent lymphoma presented with nodal disease and were more likely to have bone marrow involvement. In contrast, 71% of patients with aggressive lymphoma presented with extra-nodal disease. Five of seven (71%) patients with indolent and 22 of 29 (76%) with aggressive NHL who received an Adriamycin containing regimen as first line therapy achieved a complete response. The International Prognostic Index (IPI) was a strong predictor of both survival (P<001) and response (P=007) for the group as a whole. The IPI accurately predicted the survival of patients with aggressive NHL (P=026). This was not the case with indolent lymphomas. This study suggests that elderly patients with NHL are more likely to have aggressive disease, a diffuse pathology and an extra-nodal presentation.     

Rhabdomyosarcoma in patients older than 40 years of age

The original diagnosis of rhabdomyosarcoma (RM) was critically evaluated by histology, immunohistochemistry, and electron microscopy in a retrospective series of 25 patients older than 40 years of age. Only two of the 25 patients (8%) were verified to have RM by strict criteria. By light microscopy, the true RM had a spindle or round cell appearance and were subtyped as embryonal RM, although some pleomorphism was present. Sarcomeric differentiation was revealed by electron microscopy, and desmin and muscle actin by immunohistochemistry. Both of these tumors arose in the urogenital organs, one in the urinary bladder and the other in the prostatic region. Both patients died within 3 months of the diagnosis. The other tumors not verified as RM were pleomorphic or spindle cell sarcomas (n = 17), ten of which were considered to represent malignant fibrous histiocytoma, or had desmin and/or muscle actin, and were verified as leiomyosarcomas by electron microscopy (n = 2). There were single cases of undifferentiated carcinoma, probable neuroendocrine carcinoma, extraskeletal osteosarcoma, and pleomorphic liposarcoma. The average survival for the non-RM tumor patients was 32 months. The results show that true RM do occur in the elderly, but they are very rare. Such tumors may have clinicopathologic properties similar to embryonal RM in children both in regard to the site of origin and to the histologic picture. True RM seems to carry a worse prognosis than other pleomorphic sarcomas, and this emphasizes the need for accurate diagnosis.     

Radiation therapy in cancer patients 80 years of age and older

There is a paucity of clinical data regarding radiation therapy in elderly patients. This is a retrospective study of all patients aged 80 years and older who underwent treatment with external beam irradiation at a single site. There were a total of 183 patients treated with 226 courses of therapy. The mean age was 84 years (range: 80-98 years). Fifty-eight percent of the patients were male. The treatment was deemed palliative in 51% and curative in 49%. The primary cancer diagnoses were: prostate 36, lung 28, breast 25, head and neck 23, gastrointestinal 21, hematologic 12, gynecologic 11, skin 11, genitourinary 9, unknown primary 6, central nervous system 1. The patients were able to complete the prescribed therapy in 173 of 226 courses (77%). Treatment breaks during the radiation courses were required in 81 (36%) of the courses. Radiation therapy can be safely administered to an elderly population with both curative and palliative intent with the expectation of completion in more than 80% of patients. The reasons for inability to complete therapy as prescribed are multifactorial, but careful patient selection and attention to comorbidity may optimize outcome. Further research is needed to better define these parameters.     

Non-Hodgkin's lymphoma in patients 80 years of age or older

Background: Very elderly patients (     

Surgical treatment of esophageal carcinoma in patients eighty years of age and older

Before 1979, no patient 80 years of age or older had been operated on at our institution for esophageal cancer, while in the middle period (1980–1984), three patients were operated on, and postoperative pulmonary complications and operative death occurred in 66.7 and 33.3%, respectively. However, in the recent period (1985–1990), there was no postoperative morbidity or mortality in the five cases over age 80. On the other hand, there were 12 patients over age 80 who did not undergo operation, of whom all died of cancer. In the eight operated patients over age 80, two cases are still alive 17 and 34 months after operation. According to the above findings, when the patient's general condition is evaluated to be sufficient to tolerate the operation and the cancer is judged to be resectable, esophageal resection is thought to be indicative in all patients over eighty. © 1993 Wiley-Liss, Inc.     

高龄食管癌、贲门癌患者食管切除术结果分析

目的：探讨高龄食管癌、贲门癌患者行食管切除术的危险性及手术死亡率与年龄的关系。方法：１９８５年～１９９０ 年对４４４ 例食管癌、贲门癌患者食管切除术,根据年龄段分为两组：Ⅰ组,年龄≥６５ 岁,５６ 例,Ⅱ组,年龄＜６５ 岁,３８８ 例,比较两组术前危险因素、手术合并症及死亡率、平均住院日和长期生存率。结果：两组病例术后死亡率（３－６ ％ ｖ２－８ ％ ） ,平均住院日（２３－３ 天ｖ２２－３ 天） ,５ 年及１０ 年生存率（３４－５ ％ ｖ ３６－８ ％ ,２４－１％ ｖ２５－７％ ） 均无显著性差别。结论：高龄食管癌贲门癌患者行食管切除术并不增加手术死亡率,而长期生存率与年轻者相比无差异。     

Use of adjuvant systemic therapy for early breast cancer among women 65 years of age and older.

BACKGROUND: The National Institutes of Health (NIH) consensus statement recommends adjuvant therapy for early breast cancer irrespective of age. However, the actual use of such therapy is not well documented among women over 65 years of age. METHODS: We studied the frequency of use of adjuvant therapy and report the receipt of this therapy among 200 women aged > or = 65 years diagnosed with early breast cancer who were identified from the New Jersey State Cancer Registry. RESULTS: In this population, 28% of patients received chemotherapy alone or in combination with hormonal therapy, whereas 42% received hormonal therapy alone. Less than half of the women with estrogen receptor-negative tumors received chemotherapy alone or in combination with hormonal treatment. Adjuvant therapy was not prescribed in 30% of patients. CONCLUSIONS: Despite NIH recommendations, the frequency of use of adjuvant therapy in New Jersey is low among women over 65 years of age, regardless of their receptor status.     

Cancer incidence in the age range 0-34 years: historical and actual status in Denmark

On the basis of 55 years of continuous cancer registration in Denmark, we present cancer incidence rates, time trends and birth cohort analyses for persons aged 0-34 years. The group of 40,750 cancer patients showed a substantial over-representation of males aged 1-24 years. The cancer pattern among young (15-34 years) men was dominated by testicular cancer (35%), lymphomas (14%) and tumors of the brain (13%), while the pattern among young women was governed by invasive cervical cancer (19%), malignant melanoma (15%) and cancer of the breast (12%). In this age range, a positive time trend was seen after 1970, equivalent to average annual percentage increases of 1.9% for men and 1.8% for women, due mainly to markedly increasing trends for testicular cancer, malignant melanoma, brain tumors, thyroid cancer, skin carcinomas and skin sarcoma among men, and for brain tumors, non-Hodgkin lymphoma, malignant melanoma, skin carcinomas and thyroid cancer among women. We saw no clear time trend for breast cancer among women. The cancer pattern among children (0-14 years) was similar to that reported for other white populations.     

45岁以下子宫内膜癌患者术后3年生存影响因素分析

目的:分析45岁以下子宫内膜癌患者术后3年生存影响因素。方法:收集2009年1月至2011年12月在唐山市妇幼保健院诊断为子宫内膜癌的患者,均行子宫全切术,术后病理证实为子宫内膜癌患者88例。并根据其年龄将其分为A组（≤35岁）35例,B组（36~45岁）53例,对2组患者的生存影响因素进行单因素及多因素分析。结果:对患者的预后因素中组织学类型、病理分级、肌层浸润深度、淋巴结转移、附件转移、腹腔细胞学、雌孕激素受体等7个因素行单因素分析,结果显示组织学类型、病理分级、肌层浸润深度、淋巴结转移、附件转移、腹腔细胞学对患者的预后有影响（P均<0.05）。雌激素受体阳性患者3年生存率高于雌激素受体阴性患者,有统计学意义（P<0.05）。孕激素受体对患者预后无影响(P>0.05)。45岁以下子宫内膜癌术后放疗、化疗、孕激素治疗三者3年生存比较,无明显差异（P>0.05）。未接受治疗患者3年生存率为57.14%,低于接受放疗、化疗、孕激素治疗患者的3年生存率,均有统计学意义（P<0.05）。多因素回归分析得出肿瘤浸润深度、淋巴结转移是影响预后的独立因素。结论:45岁以下子宫内膜癌患者其发生与雌激素有关,尤其是≤35岁者,高危因素少,预后较好。对于早期45岁以下子宫内膜癌患者可考虑保留生育功能或卵巢。早期发现、早期诊断是提高45岁以下子宫内膜癌患者术后3年生存率的核心,早期手术治疗及术后辅助治疗是提高患者术后3年生存率的保障。     

Nasopharyngeal carcinoma in children under 15 years of age: A retrospective review of 65 patients

Background: Nasopharyngeal carcinoma constitutescomprises up to 5% of primary childhood cancers but literature lacks modern uniformly treated large series.Patients and methods: A retrospective review was performed of sixty-five previously untreated patients younger than 16 years of age diagnosed and treated at the Ibn Rochd Centre in Casablanca between 1988 and 1992. Forty-four percent of them were stage T₃ to T₄ and 66% stage N₂ or N₃. All patients were irradiated. Prior adjuvant chemotherapy was administered in 33 patients. Thirteen patients were lost to follow-up.Results: Local control was obtained in 85% of the 52 evaluable patients. The five-year overall survival was 42% and disease-free survival 38%. Ten relapses occurred at local and/or regional sites. Six patients have distant metastases. All 24 patients with relapse or persistent disease died despite salvage therapy. Stage, histology and dose of radiation, were statistically significant prognostic variables. Patients treated with chemotherapy followed by irradiation had a better outcome than those treated with radiation alone.Conclusions: Nasopharyngeal carcinoma in children is a rare chemosensitive tumor. However, conclusive treatment guidelines cannot be drawn from this series and prospective co-operative studies are needed for the development of more effective and less toxic therapeutic strategies.     

Hemoccult screening in selected patients. The hernia patient older than age fifty years

Two hundred and forty patients, asymptomatic relative to gastrointestinal disease, who applied for elective hernia repair, were tested as outpatients for occult blood in the stool. Thirty-eight patients had one or more positive specimens. Significant pathologic characteristics were identified by lower gastrointestinal evaluation in 23 of these patients. One patient had an adenocarcinoma (Dukes' Stage B). Eight patients had polyps of various types, 11 patients had colonic diverticula, and three patients had anorectal disease. Patient compliance was excellent and the cost-benefit ratio appeared to be acceptable.     

Cancer incidence among the south Asian and non-south Asian population under 30 years of age in Yorkshire,UK

Background:

Pt-(GpG) intrastrand crosslinks are the major DNA adducts induced by platinum-based anticancer drugs. In the cell lines and mouse models, the persistence of these lesions correlates significantly with cell damage. Here we studied Pt-(GpG) DNA adducts in circulating tumour cells (CTC) treated with cisplatin in medium upfront to systemic therapy from patients with advanced non-small-cell lung cancer (NSCLC).

Methods:

Blood was drawn before systemic treatment and the CD45/CD15-depleted fraction of mononuclear cells was exposed to cisplatin, verified for the presence of CTC by pan-cytokeratin (pCK) staining and immunoanalysed for the level of Pt-(GpG) in DNA.

Results:

Immunostaining for pCK, CD45 and subsequently for Pt-(GpG) adducts in the cisplatin-exposed cells (ex vivo) at different time points depicted distinct differences for adduct persistence in CTC between responders vs non-responders.

Conclusion:

Pt-(GpG) adducts can be detected in CTC from NSCLC patients and assessing their kinetics may constitute a clinically feasible biomarker for response prediction and dose individualisation of platinum-based chemotherapy. This functional pre-therapeutic test might represent a more biological approach than measuring protein factors or other molecular markers.     

60岁以上乳腺癌的乳腺X线影像学表现及病灶微钙化与年龄的相关性研究

目的:比较年龄60岁以上老年乳腺癌与60岁以下非老年乳腺癌患者的乳腺X线影像学表现并分析病灶微钙化阳性率与年龄的相关性。方法:回顾性分析2012年6月至2013年4月天津医科大学肿瘤医院1 959例经病理确诊的乳腺癌患者的乳腺X线影像学资料,以60岁为界分为老年组(n=512)和非老年组(n=1 447)并进行统计学分析。结果:老年组和非老年组中高密度肿块的患者分别占73.0%(330/452)和46.0%(464/1 008),等/低密度肿块的患者分别占27.0%(122/452)和54.0%(544/1 008),两组比较差异具有统计学意义(P<0.05)。老年组和非老年组中病灶微钙化阳性率分别为34.8%(178/512)和41.7%(603/1 447),两组比较差异具有统计学意义(P<0.05)。1 959例患者根据年龄<30岁、30～39岁、40～49岁、50～59岁、60～69岁和年龄≥70岁进行分组,病灶微钙化阳性率分别占58.8%(10/17)、42.8%(74/173)、41.0%(259/632)、41.6%(260/625)、38.2%(137...     

Cancer incidence among the south Asian and non-south Asian population under 30 years of age in Yorkshire, UK

Background:

Few studies have examined epidemiological differences between ethnic groups for children and young adults with cancer.

Methods:

Subjects aged 0–29 years, diagnosed between 1990 and 2005 in the former Yorkshire Regional Health Authority, were included in the analysis. Ethnicity (south Asian or not) was assigned using name analysis program and Hospital Episode Statistics data. Differences in incidence (per 1 000 000 person-years) rates and trends were analysed using joinpoint and Poisson regression analysis.

Results:

Overall cancer incidence was similar for south Asians (12.1, 95% CI: 10.7–13.5; n=275) and non-south Asians (12.6, 95% CI: 12.2–13.1; n=3259). Annual incidence rates increased significantly by 1.9% per year on average (95% CI: 1.2–2.6%), especially for south Asians (7.0% 95% CI: 4.2–9.9%).

Conclusion:

If present trends continue, the higher rate of increase seen among south Asians aged 0–29 years in Yorkshire will result in three times higher cancer incidence than non-south Asians by 2020.