In order to assess the predictive capacity of chronological age for survival, an analysis of prognostic variables was performed on 277 patients with Non-Hodgkin's Lymphoma, 84 of whom were older than ...65 years. All patients were seen at a single institution, and elderly patients, who might otherwise have been excluded from study analysis, were included. Seventeen clinical, radiological and laboratory parameters were evaluated and subjected to univariate and multivariate analyses. Patients older than 65 years had a significantly poorer survival than those younger than 65 years. When the whole group was considered in a multivariate (Cox) model, the factors that independently predicted a longer survival were a good performance status, age <65 years and a low grade histological subtype. When patients older and younger than 65 years were analyzed separately the prognostic variables in the elderly were found to be similar to those in younger patients. The predictive capacity of chronological age was found to be influenced by a poor performance status, the presence of concomitant disease, the dose intensity and tolerance of the treatment given, as well as the physiological reserve of the patient. It is concluded that chronological age is a multifactorial prognostic parameter encompassing a number of patient and treatment factors, all of which must be considered when evaluating the capacity of chronological age to predict survival in patients with Non-Hodgkin's Lymphoma.
The Eastern Cooperative Oncology Group (ECOG) trial of adjuvant cyclophosphamide, methotrexate, fluorouracil, and prednisone (CMFP) or CMFP plus tamoxifen (CMFPT) for 1 year compared with observation ...alone in 265 postmenopausal patients with node-positive breast cancer is reported with 74 months median follow-up. Overall relapse-free survival tended to favor CMFPT (P = .08), but no survival differences existed between any treatment group. The addition of tamoxifen to CMFP led to slightly (but not significantly) better relapse-free status in all subgroups analyzed. Subgroup analysis based on stratification variables showed significant benefit from CMFP (+/- T) only in estrogen receptor (ER)-negative patients with respect to disease-free status (P = .0003), but not survival (P = .54). Relapse-free status was actually worse for CMFP-treated patients with ER-positive tumors, but not significantly so (P = .15). By multivariate analysis other significant risk factors for relapse-free status were primary tumor size, number of nodes pathologically involved, and the number of nodes examined. ER status was prognostic only for the observation group with the benefit from chemotherapy on ER-negative patients obliterating this difference in treated patients. Survival was affected by the number of involved nodes, tumor size, presence of tumor necrosis, and patient obesity. Analysis of toxicity showed elevation of liver enzymes during the first year to be more common in the observation group compared with those patients receiving adjuvant treatment and to be associated with early recurrence. Toxicity from adjuvant treatment persisted beyond termination of therapy in 53% of patients, but was usually mild and self-limited. We conclude CMFPT offers relapse-free survival benefit in ER-negative patients, but the value of chemotherapy in ER-positive postmenopausal, node-positive patients must be questioned.
The Eastern Cooperative Oncology Group has conducted a retrospective review of their experience of 96 patients with a tissue diagnosis of malignant mesothelioma treated between 1972 and 1980 on four ...separate sarcoma chemotherapy protocols. Thirty‐two of the 96 patients were diagnosed and treated in South Africa. There were 75 males and 21 females with an age range of 27 to 78 with a median of 58.1 years. All, except for 28 patients, had some form of prior therapy. The median time from the onset of symptoms to diagnosis was 12 weeks; from the diagnosis to randomization was 15.1 weeks. Only 12 of the 96 patients demonstrated an objective regression. The responses were 7/51 on Adriamycin with 2 complete responses (complete responses—38 weeks and 52 weeks), 2/24 on Adriamycin combinations, 2/7 on cycloleucine, 1/3 on bleomycin, and 0/10 on non‐Adriamycin combinations. Only 1/28 responded to a cross‐over therapy (Adriamycin). The median survival from the start of protocol chemotherapy was 7.4 months and 7.5 months for Adriamycin treated patients. The median survival for responders was 29.9 months, compared to 6.3 months for nonresponders. The median survival for this entire series from the time of first symptoms was 15.2 months. The median survival for the 7 patients with abdominal mesothelioma was 12 weeks. There was a slight improvement in survival for the South Africans as compared to the Americans. Malignant mesothelioma in this series, was a rapidly lethal, nonresponsive disease whose treatment will require new therapies. Cancer 52:1981‐1985, 1983.
Forty women with metastatic breast cancer were randomized to receive either mitomycin-C (MMC) (21 patients) or vindesine (19 patients) with high dose medroxyprogesterone acetate (MPA). Response rates ...were not significantly different (33% for MPA and MMC and 28% for MPA and vindesine); the duration of response was better for patients receiving the MMC combination (median of 10.5 months versus 6 months for those on the vindesine combination).
The riminophenazine compound clofazimine has been shown to be a potent inhibitor of hepatocellular carcinoma (HCC) in vitro. Therapeutic benefit was claimed for patients with HCC treated with ...clofazimine in a recent clinical trial. The current trial was initiated to evaluate response and survival of patients with HCC receiving clofazimine plus doxorubicin. Twenty-eight patients were entered into the study, of whom 27 were evaluable for response and survival. No patients had a complete or partial response, and 9 had stable disease. The median survival time was 7 weeks. Toxicity was mild with yellow pigmentation of the skin resulting from the clofazimine, and leukopenia, nausea, vomiting and mucositis as expected from doxorubicin. Further studies using other riminophenazine compounds are warranted.
In a randomized crossover study, 181 patients over the age of 65 with recurrent breast cancer received either tamoxifen or cyclophosphamide, methotrexate, and fluorouracil (CMF). After progression on ...tamoxifen, a hormone withdrawal period was required. Because of altered pharmacokinetics with aging, creatinine clearance was used in calculating the dose of CMF. Response rates were 45% on tamoxifen and 38% on CMF, with median durations of 10.4 and 7.9 months, respectively. Survival rates tended to favor tamoxifen as the initial treatment even in estrogen-receptor-negative patients. Additional disease control with hormone withdrawal occurred in 23% of patients, and this benefit was highly correlated with prior hormone response. We conclude that initiation of hormone therapy rather than CMF chemotherapy is justified in almost all situations in elderly patients, and combination chemotherapy, is safe and useful after hormone failure if modified on the basis of renal dysfunction.
Daytime plasma melatonin values were measured by radioimmune assay in 86 patients with breast cancer; 280 assays were done and compared with the clinical status of the patients. Patients in the ...advanced disease group had significantly higher levels than those in the adjuvant treatment group, and patients with progressive disease had significantly higher values than those in remission or with stable disease. No significant differences were found between different dominant metastatic disease sites. Multiple-regression tests showed a significant inverse correlation between survival and melatonin values.
An analysis was performed on 127 consecutive women with advanced measurable ovarian cancer to evaluate factors predicting for survival. All patients received cis-platinum-based chemotherapy as ...treatment for stage IIIB to stage IV disease. Eighteen clinical, radiological, and biochemical parameters were subjected to univariate and multivariate analyses. Recursive partitioning and amalgamation (RPA) was used to define prognostic subsets with different survival potentials. In the univariate analysis, factors that predicted for survival were weight loss, histology, stage, number of metastases, presence of ascites, size of the residual tumor, and rate of tumor response. When these significant variables were included in a Cox model, advanced stage of disease, histology other than adenoserous carcinoma, the presence of tumor bulk, and a slow rate of tumor response independently predicted a poorer survival. Using the three disease-related prognostic variables, a RPA model was derived and three groups were identified with median survival times of 76, 28, and 21 months, respectively (P = 0.001). The best survival time of 76 months was seen in patients with stage III, nonbulky, adenoserous ovarian carcinoma. It is concluded that the rate of tumor response is important in predicting the outcome of patients with ovarian cancer. Furthermore, the interactions between prognostic factors are emphasized by the RPA model and a subgroup of patients with a projected 10-year survival of 50% is identified.
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