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Biomedical subjects

G Falkson

Publications and source records attributed to G Falkson.

At least 163 records · Page 9Linked to original sources
PubMed1985

Adjuvant tamoxifen treatment of elderly women with stage II breast cancer. A double-blind comparison with placebo.

One hundred seventy elderly women with stage II breast cancer, stratified on the basis of the number of positive axillary nodes and estrogen receptor status, were randomly assigned to receive tamoxifen or placebo for 24 months in a prospective, double-blind, adjuvant trial. The median age was 71 years with a range from 65 to 84 years. The overall percentage of patients disease-free at 4 years was 76% for those given tamoxifen and 52% for those given placebo (p = 0.0004). Benefit was seen in all subgroups of patients treated with tamoxifen. Two years of tamoxifen therapy represents an effective postoperative adjuvant treatment for elderly women with stage II breast cancer, resulting in improved time to relapse, statistically fewer distant first recurrences, and minimal toxicity. No improvement in overall survival has been seen yet.

Aged↗
PubMed1985

Hematological toxicity: experience with anthracyclines and anthracenes.

Documented is hemopoietic toxicity encountered in patients with primary liver cancer (PLC), metastatic breast cancer, and colorectal cancer treated with various anthracyclines (doxorubicin [adriamycin, ADR], 4-'epidoxorubicin [4-'epiADR], and esorubicin) or anthracenes (mitoxantrone and bisantrene, as single agents as well as different combinations). Mitoxantrone, 14 mg/m2 three times weekly, was significantly more toxic than ADR, 60 mg/m2 three times weekly, for patients with PLC (P less than 0.01). In patients with colon cancer the toxicity of esorubicin did not differ significantly from that of 4-'epiADR. There was a tendency toward cumulative leukopenia with mitoxantrone and esorubicin, and cumulative thrombocytopenia with mitoxantrone and ADR. Although nadir counts for cycles 1 and 3 were similar, the percentage of patients receiving the full planned dose by the third cycle differed with the different drugs and in the different disease categories. Doxorubicin can be effectively combined with other cytostatics (e.g., cyclophosphamide + ADR + fluorouracil) to give improved results without undue hemopoietic toxicity in patients with breast cancer.

Anthracenes↗
PubMed1984

Eastern Cooperative Oncology Group experience with chemotherapy for inoperable gallbladder and bile duct cancer.

In a prospective randomized Eastern Cooperative Oncology Group (ECOG) study, 53 eligible and evaluable patients with advanced gallbladder carcinoma and 34 with advanced bile duct carcinoma were treated with oral 5-fluorouracil (5-FU) or with oral 5-FU plus streptozotocin (Stz) or oral 5-FU + Methyl-CCNU (MeCCNU). Severe toxicity occurred in 2 of 30 patients receiving 5-FU (7%), in 14 of 26 receiving 5-FU + Stz (54%), and in 12 of 31 receiving 5-FU + MeCCNU (39%). Five of 53 patients with gallbladder carcinoma (2/18 [11%] on 5-FU, 2/16 [12%] on 5-FU + Stz, and 1/19 [5%] on 5-FU + MeCCNU) had objective response to treatment. There was no significant difference between treatments with respect to response or survival. Three of 34 patients with bile duct cancer (1/12 [8%] on 5-FU, 0/10 on 5-FU + Stz, and 2/12 on 5-FU + MeCCNU) had objective response to treatment. There was no significant difference between treatments with respect to response or survival. Patients with prior chemotherapy were randomized between MeCCNU alone and Stz alone. Among such patients, only 1 of 17 patients who had prior chemotherapy with other agents responded to MeCCNU alone, and none of 14 patients responded to Stz alone.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1984

Primary liver cancer. An Eastern Cooperative Oncology Group Trial.

One hundred ninety-two patients with unresectable primary liver cancer studied by members of the Eastern Cooperative Oncology Group (ECOG) were evaluable in a prospectively randomized clinical trial. Patient discriminants such as performance status were carefully evaluated to assess their influence on prognosis and to evaluate the importance of patient status on response and survival. Patients who were totally bedridden or with signs of overt liver failure were not entered on study. The median survival time for all evaluable previously untreated patients was 17 weeks (19 weeks for North American and European, and 10 weeks for South African black patients). Among the South African patients, however, there was a significantly larger proportion with an initially poor performance status. Prognostic variables (performance status, jaundice, and reduced appetite) dominate any differences among the treatments studied. Among North American and European patients on intravenous (IV) 5-fluorouracil (5-FU) + Methyl-CCNU (MeCCNU) + Adriamycin (ADM, doxorubicin), the 19% response rate is offset by 63% with severe toxicity and a median survival time of only 17 weeks, making this treatment unacceptable clinically. The median survival time of North American and European patients treated with IV 5-FU +/- MeCCNU was 28 weeks in contrast to a median survival time of 12 weeks with ADM (P less than or equal to 0.01). EST 2273 was the ECOG study of patients with primary liver cancer. The results of the first part of the trial were published in 1978. This report updates those findings and reports the results of patients entered subsequently on the second part of that study after it was amended in 1979. With more than 300 evaluable patients in EST 2273, this duet of studies is the largest ever conducted in patients with primary liver cancer, and draws a new baseline from which to measure the disease and its response to treatment.

Adenoma, Bile Duct↗
PubMed1984

Randomized trial of chlorozotocin, neocarzinostatin, or methyl-CCNU in patients with malignant melanoma.

One hundred twenty-two patients with disseminated malignant melanoma were randomized using an unbalanced randomization to receive chlorozotocin, neocarzinostatin, or MeCCNU. Of the 114 evaluable patients, 46 received chlorozotocin, 47 received neocarzinostatin, and 21 received MeCCNU. The response rates to these three drugs were 9%, 4%, and 14% respectively. Median survival times were 4.2, 3.4, and 5.8 months respectively. Toxicity was acceptable with all three agents. Chlorozotocin and neocarzinostatin do not appear to offer any improved response rates over MeCCNU for patients with disseminated malignant melanoma.

Adult↗
PubMed1984

Neocarzinostatin versus m-AMSA or doxorubicin in hepatocellular carcinoma.

Sixty-one of 76 patients entered on a prospective randomized trial of neocarzinostatin ( NCZ ) versus m-AMSA or doxorubicin were eligible for analysis. Among these 61 patients at least one episode of severe toxicity was documented in 39% of patients on NCZ and 58% on m-AMSA. Fifty-one of the 61 patients were previously untreated with chemotherapy. Among these 51 patients objective response was documented in two of 25 patients treated with NCZ , none of 17 treated with m-AMSA, and one of nine treated with doxorubicin. Among previously untreated North American and European (NA/E) patients the median survival times were: NCZ 11 weeks and m-AMSA 12 weeks. The data on South African (SA) patients with similar entrance criteria entered on earlier Eastern Cooperative Oncology Group trials were analyzed with that from the randomized trial and show that for SA patients the median survival times were: NCZ , 11 weeks (31 patients); m-AMSA, 13 weeks (33 patients); and doxorubicin, 15 weeks (29 patients).

Aminoacridines↗
PubMed1983

Malignant mesothelioma. The Eastern Cooperative Oncology Group (ECOG) experience.

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.

Abdominal Neoplasms↗
PubMed1983

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↗
PubMed1983

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↗
PubMed1983

A phase II study of m-AMSA in patients with malignant mesothelioma.

Nineteen patients with histologically confirmed malignant mesothelioma were treated with m-AMSA at the University of Pretoria. All patients had evaluable disease and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-3. m-AMSA 120 mg/m2 was given IV every 3 weeks. Hematopoietic suppression was the major side-effect. Eleven patients developed leukopenia. There was one partial response (16 weeks), and a no change status was documented in 12 patients (median duration of 20 weeks). The median survival time of patients was 27 weeks from entry on study. Radionuclide ventricular ejection fraction tests were performed to evaluate cardiac function.

Abdominal Neoplasms↗
PubMed1983

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↗
PubMed1983

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↗
PubMed1983

Amsacrine cardiotoxicity: assessment of ventricular function by radionuclide angiography.

Serial assessment of ventricular function by means of a nuclear medicine technique was performed in six patients with malignant disease receiving chemotherapy with amsacrine. Two patients who received treatment long enough so that greater than 580 mg/m2 of the drug was administered showed a significant decrease in left ventricular ejection fraction. Four patients who received total doses of 325-510 mg/m2 of amsacrine did not experience significant change in their cardiac function.

Aged↗