Severe toxicity with cytorhodin S.
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Adolescent↗
Biomedical subjects
H C Falkson
Publications and source records attributed to H C Falkson.
Plasma melatonin in patients with breast cancer.
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.
Biomarkers, Tumor↗
Adjuvant trial of 12 cycles of CMFPT followed by observation or continuous tamoxifen versus four cycles of CMFPT in postmenopausal women with breast cancer: an Eastern Cooperative Oncology Group phase III study.
A prospectively controlled randomized trial to compare the adjuvant efficacy of 12 cycles of cyclophosphamide, methotrexate, fluorouracil, prednisone, and tamoxifen (CMFPT) followed by observation or a total of 5 years of continuous tamoxifen versus four cycles of CMFPT followed by observation in postmenopausal women with operable node-positive breast cancer was started by the Eastern Cooperative Oncology Group (ECOG) in 1982. In 1986 the study was modified to allow patients on CMFPT X 12 plus continuous tamoxifen to be rerandomized after completing 5 years of tamoxifen to either continue for life or to stop therapy. Patients were stratified for number of involved nodes and estrogen-receptor (ER) status and randomized to receive one of three treatments: CMFPT X 4, CMFPT X 12, or CMFPT X 12 plus continuous tamoxifen. Of 962 patients entered on the study, 803 were eligible. Life-threatening toxicity occurred in 75 and lethal toxicity in seven patients. Median follow-up is 4.1 years; 279 patients had recurrent disease. Time to relapse (TTR) is significantly longer for patients on CMFPT X 12 plus continuous tamoxifen than for CMFPT X 4 (P = .002), or CMFPT X 12 (P = 0.05). Differences between four or 12 cycles of CMFPT are not significant; relapse-free rates at 5 years are 61% for CMFPT X 12 plus continuous tamoxifen, 51% on CMFPT X 12, and 52% on CMFPT X 4. Treatment differences in overall survival are not significant. Hormone receptor status and number of involved nodes were found to be significant prognostic parameters.
Antineoplastic Combined Chemotherapy Protocols↗
Treatment and prognosis of metastatic carcinoma of unknown primary: analysis of 100 patients.
One hundred patients with metastatic carcinoma of unknown primary were analyzed to assess the importance of prognostic factors on survival. Patients were treated with cytostatic combinations, single drugs, or symptomatic care only. Response in the treatment groups ranged from 10% to 33%. The median survival of all patients was 124 days. In a univariate analysis good performance status, the presence of lymph node metastases, and the absence of liver metastases favorably influenced survival. In a Cox proportional hazards model, good performance status contributed significantly to a better survival. In addition there was a trend for female patients, patients with lymph node metastases, and patients without liver metastases to survive longer. These patient subsets deserve optimal treatment despite the dismal prognosis of this disease.
Adenocarcinoma↗
Ifosfamide and mesna in the treatment of malignant disease mesna as urothelial protector.
One hundred and forty-six patients with advanced malignant disease were treated with 6 different dosage schedules of ifosfamide (IFX). Mesna was used as urothelial protector. With mesna, urothelial toxicity was moderate, and single doses of up to 7 g/m2 could be administered without intolerable urotoxicity. Leukopenia was the dose-limiting factor in this study. Unexpected pulmonary edema occurred in 3 patients. Therapeutic results were disappointing. A malignancy identified in this study that warrants further investigation with IFX and mesna, is malignant mesothelioma.
Adult↗
CAF and nasal buserelin in the treatment of premenopausal women with metastatic breast cancer.
This study was undertaken to determine whether intranasally administered buserelin, a gonadotrophin releasing hormone analog agonist, can be given with CAF to premenopausal women with advanced and/or metastatic breast cancer, and to assess toxicity and therapeutic effect. Of 24 women entered into the study 22 were evaluable; objective responses were documented in 18 patients (seven CR and 11 PR). The median time to treatment failure was 402 days. Buserelin, given with CAF, was well tolerated with the only additional side-effect being hot flushes. Amenorrhea occurred in 13/17 menstruating women and serum estradiol levels decreased to postmenopausal values in all patients.
Administration, Intranasal↗
Prognostic factors for survival in hepatocellular carcinoma.
Associations between patient characteristics and survival were investigated in 432 patients with hepatocellular carcinoma. Those patients were prospectively studied by the Eastern Cooperative Oncology Group, and each had his or her diagnosis reconfirmed by a pathology review panel. There were 301 North American and 131 South African patients. Sixty-nine % of the North American patients and 82% of the South African patients were male. There were 187 Black patients, 62 of whom were from North America. The study population is unique among hepatocellular carcinoma patients in that eligibility, evaluability, and endpoint definitions were standardized, and patients from both North America and South Africa received similar treatments at a similar time. Factors with the most significant adverse effect on survival are impaired performance status, male sex, older age, and disease symptoms (jaundice and reduced appetite). There is no apparent difference in survival between White and Black patients within North America, but North American patients survived longer than South African patients. Among the different therapies, p.o. 5-fluorouracil was associated with the poorest median survival time (6 wk), and i.v. 5-fluorouracil plus semustine with the best median survival time (24 wk).
Adult↗
Malignant pleural mesothelioma treatment: the current state of the art.
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Combined Modality Therapy↗
High-dose medroxyprogesterone acetate plus mitomycin-C or vindesine in the treatment of advanced breast cancer.
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).
Adult↗
Actual versus ideal weight in the calculation of surface area: effects on dose of 11 chemotherapy agents.
This study of 2382 breast, 182 rectal, 817 colon, and 351 lung cancer patients treated with combination chemotherapy on eight phase III Eastern Cooperative Oncology Group protocols indicates that 69% would receive a higher dose of at least one drug if surface area were calculated from actual weight rather than from the minimum of actual and ideal weight. Forty-eight percent of the patients would have at least a 10% increase in drug dose based on actual weight. Only on the premenopausal adjuvant breast cancer protocol and among women on the rectal adjuvant study do the differences in dose based on actual rather than ideal weight increase significantly with age. On the postmenopausal adjuvant breast study and on the lung cancer study, the differences in dose decrease significantly with age. For all age decades and both sexes within each protocol, the mean differences between dose based on actual and dose based on ideal weights were on the same order as the rounding factors for the 11 drugs studied. From the literature on the effect of doses of common chemotherapies on leukopenia, it appears that the percent of hematologic toxicity would not be raised to unacceptable levels by using actual weight to set doses.
Adult↗
High-dose medroxyprogesterone acetate in combination with vindesine in advanced breast cancer.
Forty-three evaluable women with metastatic breast cancer received treatment with high-dose medroxyprogesterone acetate (MPA) plus vindesine. Patients tolerated treatment well, no lethal toxicities occurred. The commonest side-effects were hemopoietic, with leukopenia documented in 22 patients. Symptoms of peripheral neuritis occurred in 10 patients. A response rate of 28% (12 out of 43 patients) was seen. Ten of the responding patients had multiple prior chemotherapeutic agents. These results indicate that the combination of MPA and vindesine is not of value in patients with advanced breast cancer.
Adult↗
Prospective evaluation of carcinoembryonic antigen levels and alternating chemotherapeutic regimens in metastatic breast cancer.
Ninety-seven eligible and evaluable women with metastatic breast cancer were placed on a prospective clinical protocol to evaluate the use of continuous cyclic therapy with dibromodulcitol, doxorubicin, vincristine, tamoxifen, and fluoxymesterone (DAVTH) v DAVTH alternating with cyclophosphamide, methotrexate, 5-fluorouracil, and prednisone (CMFP); and the use of pretreatment and serial carcinoembryonic antigen (CEA) levels in these patients. Continuous DAVTH and DAVTH/CMFP were equivalent therapies with respect to response rates, time to treatment failure (TTF), and survival. Pretreatment CEA levels were elevated (greater than 5 ng/mL) in 42/97 patients and less than 5 ng/mL in the remaining patients. Patients with elevated pretreatment CEA levels were more likely to be estrogen receptor (ER) positive (P = .006), to have prolonged disease-free intervals (P = .017), to have hepatic (P = .004) and/or osseous (P = .01) metastases, and to have multiple sites of metastatic disease (P = .004). Pretreatment CEA levels did not significantly predict for overall response rates, TTF, or survival; nonetheless, those patients with low pretreatment CEA levels had more complete responses (CRs) (16/55 v 4/42; P = .02). Serial CEA levels during therapy revealed a number of interesting patterns. During the first 4 months of treatment, serial CEA levels in responding patients either (1) progressively declined (15/29 women with elevated pretreatment CEA levels), or (2) initially rose significantly (mean, 243% of pretreatment value) and then declined (14/29 women with elevated pretreatment CEA levels). Peak CEA levels in the latter patients were seen 27 to 135 days following initiation of cytotoxic therapy. In some patients the initial increase in the CEA level was incorrectly interpreted as evidence of impending disease progression. CEA levels frequently increased around the time of clinical disease progression. However, rising CEA levels rarely provided a clinically meaningful lead time before the appearance of other clinical evidence of disease progression. These data suggest that routine pretreatment and monthly serial CEA levels in metastatic breast cancer patients have minimal use in clinical practice. Two further noteworthy findings were observed in this prospective study. First, patients with an unknown ER status had a prolonged median survival when compared with patients with ER positive or negative tumors; this appeared to be related to prolonged disease-free intervals in ER unknown patients. Second, two case of secondary acute leukemia were seen in patients treated with continuous DAVTH therapy.
Antineoplastic Combined Chemotherapy Protocols↗
The Eastern Cooperative Oncology Group experience with cyclophosphamide, adriamycin, and 5-fluorouracil (CAF) in patients with metastatic breast cancer.
Data on 162 women (90 premenopausal and 72 postmenopausal) with metastatic breast cancer randomized to receive cyclophosphamide, Adriamycin (doxorubicin) and 5-fluorouracil (CAF) on two Eastern Cooperative Oncology Group (ECOG) protocols were analyzed. Twenty-three percent had complete remission; 39% had partial remission; 28% had no change; and 3% had disease progression. Of those patients in whom receptors were known, response rates were 65% for estrogen (ER)-receptor positive and 70% for ER-negative patients. The median duration of response was 11.4 months. The median survival time from the start of CAF was 20.2 months. The response rate, time to treatment failure (TTF), and median survival time were superior in the premenopausal women. These differences ceased, however, to be statistically significant in logistic models. Factors significantly associated with longer TTF and longer survival were as follows: one or two organs with metastases (TTF, P less than 0.0001; survival, P less than 0.0001); dominant site other than soft tissue (TTF, P less than 0.0001; survival, P = 0.05); and an initial good performance status (TTF, P = 0.007; survival, P = 0.02). Patients with ER-positive disease had a significantly longer median survival time (P = 0.003).
Antineoplastic Combined Chemotherapy Protocols↗
Adjuvant chemotherapy for operable breast cancer in postmenopausal women.
Survival figures of women with operable breast cancer reached a plateau 40 years ago. It was only with the advent of adjuvant chemotherapy that these figures showed a dramatic improvement. Data obtained in 105 postmenopausal women with operable breast cancer, treated at our clinic, are presented. Patients with axillary node disease were treated on four different protocols: cyclophosphamide + methotrexate + fluoro-uracil (CMF) with or without immunotherapy was compared with CMF + vincristine + prednisone, while other studies compared observation only with CMF + prednisone and CMF + prednisone + tamoxifen. Patients older than 65 years received tamoxifen or placebo. Patient discriminants and treatment regimens are discussed. Results indicating that certain subsets of postmenopausal women definitely need adjuvant chemotherapy are presented. The literature is briefly reviewed and the motivation for our new studies explained.
Aged↗
Combination of dacarbazine, mitomycin C, 5-fluorouracil and vincristine in advanced colorectal cancer.
Thirty patients with advanced measurable colorectal cancer received monthly courses of a combination of dacarbazine, mitomycin C, 5-fluorouracil, and vincristine (FIVMit-Or). Four of the patients had received prior chemotherapy. Two patients were not evaluable for response. Objective response was obtained in four patients. Severe toxicity was encountered in 11 patients. It is concluded that unlike the four-drug combination of 5-fluorouracil, DTIC, vincristine and BCNU (FIVB), the present regimen did not have significant antitumour activity in advanced colorectal cancer.
Adult↗
A phase II study of high-dose medroxyprogesterone acetate in advanced breast cancer.
Twenty-three evaluable patients with advanced breast cancer were treated with MPA, 1,400 mg/m2 daily PO for the first 6 months, and 500 mg/m2 daily PO thereafter. The median total dose was 191,400 mg in 88 days, with the maximum dose given to date 522,600 mg in 282 days. Most patients tolerated high-dose MPA well. Side-effects were minimal and reversible. The commonest side-effects were tremor or edema. The CR plus PR rate was five of 23 (22%). All responding patients were over 50 years of age and had a good performance status. Hormone receptor status was known in four patients only, so that no correlation between receptor status and response could be drawn. MPA appears to be a useful hormone for use in the management of breast cancer. Optimal dosage remains to be determined.
Adult↗
A randomized trial of five and three drug chemotherapy and chemoimmunotherapy in women with operable node positive breast cancer.
Women with breast carcinoma and four or more involved ipsilateral axillary lymph nodes were randomly assigned to receive an induction course and 2 yr of maintenance chemotherapy with cyclophosphamide, methotrexate and 5-fluorouracil (CMF, 150 patients), CMF plus vincristine and prednisone (CMFVP, 166 patients), or chemoimmunotherapy with CMF plus the methanol extraction residue of BCG (CMF-MER, 85 patients). After 5 yr of accrual and a median follow-up of 34 mo, CMFVP is superior to CMF (p less than 0.01) with disease-free survival estimates at 4 yr of 60% for CMFVP compared to 45% for CMF. The disease-free survival advantage of CMFVP over CMF was greater in postmenopausal (p = 0.02) than in premenopausal patients (p = 0.09). CMF-MER was similar to CMF alone. CMF related side effects were similar in each regimen (see text), except for a greater incidence of leukopenia during induction with CMF than with CMFVP (p less than 0.01).
Adult↗
Phase II trial of spirogermanium for treatment of advanced breast cancer.
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Adult↗