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Biomedical subjects

G Falkson

Publications and source records attributed to G Falkson.

At least 145 records · Page 8Linked to original sources
PubMed1986

Phase II study of 4'-deoxydoxorubicin in advanced colorectal cancer.

Thirty-three patients with advanced colorectal cancer were entered on a phase II study of 4'-deoxydoxorubicin (esorubicin) (30-35 mg/m2 q 3 weekly). Objective response was documented in 4 of 25 previously untreated patients and in none of 8 previously treated patients. Toxicity was acceptable with grade 3 or 4 leukopenia occurring in 8 patients. Complete alopecia occurred only in 4 patients and gastro-intestinal toxicity was mild. A significant decrease (greater than 10%) of the left ventricular ejection fraction occurred in 8/23 patients who received greater than 2 courses of treatment.

Adult↗
PubMed1986

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↗
PubMed1986

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↗
PubMed1986

Age as a prognostic factor in recurrent breast cancer.

The effect of age as a prognostic factor in recurrent breast cancer was studied in 1,168 patients treated on Eastern Cooperative Oncology Group (ECOG) protocols. Survival was significantly shorter in patients less than 35 years of age (P = .03). This was true even when other good prognostic factors were present. Eighteen prognostic factors were analyzed, and the effect on survival in each of six age groups was studied. Patients with better performance status, less than three sites of metastases, and without visceral or nodal metastases had a better survival time. A Cox proportional hazards model of survival showed that younger age groups, irrespective of menopausal status, had shorter survival times. The predicted median survival times after the first recurrence were 491 days for patients less than 35 years of age, 590 days for patients 36 to 45 years of age, and 700 days for those greater than 45 years of age.

Adult↗
PubMed1986

Anxiety levels in patients randomized to adjuvant therapy versus observation for early breast cancer.

We studied anxiety levels in 68 patients who had been randomized to adjuvant chemotherapy v observation on two Eastern Cooperative Oncology Group (ECOG) protocols. All subjects were women who had undergone total or modified radical mastectomy for breast cancer. Immediately before breast protocol randomization and again 3, 6, and 12 months later, patients completed two self-report measures: the State-Trait Anxiety Inventory and the SCL-90. There were no consistent trends in anxiety levels over time. At each test point, patients under observation displayed higher anxiety scores than did patients receiving adjuvant therapy, but these differences failed to attain statistical significance. Power calculations indicate that these results rule out the possibility of major differences in anxiety levels among patients randomized to observation v adjuvant therapy, but a larger patient sample is required before a definitive statement can be made about smaller differences.

Aged↗
PubMed1986

Combination chemotherapy compared to tamoxifen as initial therapy for stage IV breast cancer in elderly women.

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.

Aged↗
PubMed1986

Oral idarubicin in combination with cytosine-arabinoside in previously untreated patients with acute non-lymphocytic leukemia.

Twenty-six previously untreated patients with acute non-lymphocytic leukemia (ANLL) were treated with oral idarubicin and cytosine-arabinoside (Ara-C). The median age of the patients was 44 years (range, 11-72). In 23 of the 26 patients a hypoplastic marrow, with a peripheral white cell count of less than 1,000/mm3 after treatment, was documented. Treatment was well tolerated with minimal symptoms of nausea and vomiting. Diarrhea was observed in three patients and stomatitis in nine patients. Alopecia was documented in only six patients. A complete remission (CR) was obtained in 12 patients (median duration 25 weeks). The median time to CR was 3.4 weeks (range, 1.4-5). Ten of the 26 patients were alive 6 months after the start of induction treatment, while a further four patients who were in the study for less than 6 months are alive and in remission at 5, 4, 3, and 3 months, respectively. Eight of 12 patients in whom bone marrow aplasia was documented achieved a CR; perhaps the drug dosages used in this study were suboptimal.

Acute Disease↗
PubMed1985

Gonadotrophin-releasing hormone analogue agonists--a new approach in advanced prostatic cancer.

Gonadotrophin-releasing hormone analogue agonist administration, preferably by intranasal spray, is an effective, simple and safe way to achieve androgen deprivation in the treatment of advanced prostatic cancer without causing the psychological problems of castration or the treatment-associated morbidity and mortality of oestrogen administration. Preliminary results are promising but need further confirmation in larger trials and longer follow-up.

Administration, Intranasal↗
PubMed1985

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↗
PubMed1985

Advanced ovarian carcinoma. Factors influencing survival.

One hundred ten patients with advanced ovarian carcinoma (Stages IIIA, IIIB, and IV) were evaluated for survival. They received as first treatment one of the following regimens: melphalan (L-PAM) (41 patients), cyclophosphamide plus methotrexate plus 5-fluorouracil (CMF) (16 patients), cyclophosphamide plus doxorubicin plus 5-fluorouracil (CAF) (17 patients), cyclophosphamide plus doxorubicin plus hexamethylmelamine plus cisplatin (CHAD) (13 patients, thiotepa plus methotrexate (TM) with fixed rotation with CAF (TM/CAF) (17 patients), and 6 patients received other chemotherapy as first treatment. There was no significant difference in survival time with the various treatment arms despite differences in response rates. Patients with Stage IIIA had significantly longer survival than those with Stages IIIB and IV (P less than 0.01). Patients with good performance status (PS 0) had significantly better survival than those with poor performance status (PS 3-4) (P less than 0.02). At this time the improved response rates on combination chemotherapy has not given improved survival rates, and disease stage and performance status remain of prime importance in survival prediction.

Adult↗
PubMed1985

A retrospective study of earliest indicators of recurrence in patients on Eastern Cooperative Oncology Group adjuvant chemotherapy trials for breast cancer. A preliminary report.

A retrospective review of the Eastern Cooperative Oncology Group adjuvant chemotherapy studies EST 5177 and EST 6177 was performed in order to ascertain the first indicator of relapse in women with breast cancer and pathologically positive axillary lymph nodes. Of 856 evaluable patients, 208 have relapsed. In 175 patients who relapsed, the first indicator could be clearly identified: symptoms, 36%; patient self-examination, 18.3%; physical examination by the physician, 19.4%; abnormal blood chemistries, 12%; bone scans, 8%; chest x-rays, 5.1%; and mammograms, 1.1%. Although 74% of recurrences are therefore detected clinically, in a sizable proportion (26%), the ancillary tests were the earliest indicators of relapse. The manner of detection was not influenced by nodal, estrogen receptor (ER), or menopausal status. These results suggest that the follow-up schedule currently employed by ECOG appears reasonable.

Breast Neoplasms↗
PubMed1985

A randomized comparison of cyclophosphamide, Adriamycin, and 5-fluorouracil with triethylenethiophosphoramide and methotrexate, both as sequential and as fixed rotational treatment in patients with advanced ovarian cancer.

The combinations of triethylenethiophosphoramide and methotrexate (TM) and cyclophosphamide, Adriamycin (doxorubicin), and 5-fluorouracil (CAF) were compared, both as sequential and fixed rotational treatments for advanced ovarian cancer, with L-phenylalanine mustard (L-PAM). Treatment with CAF produced a higher response rate (25% complete responses plus 31% partial responses) than treatment with L-PAM (15% complete responses plus 18% partial responses). A fixed rotation of TM and CAF resulted in longer survival (median of 15 months and 75th percentile of 27 months) than sequential treatment with TM initially, followed by CAF upon failure (median of 12 months and 75th percentile of 22 months). The fixed rotation of TM and CAF also increased progression-free survival (median of 12 months and 75th percentile of 24 months) over that achieved by initial treatment with TM (median of 6 months and 75th percentile of 15 months) or L-PAM (median of 9 months and 75th percentile of 21 months). Most patients (96%) on the fixed rotation were treated with both TM and CAF. Fewer patients (62%) on the sequential schedule with TM actually received both combination regimens, and even fewer patients (37%) beginning on CAF ever crossed over to TM. Patient age of 50 years or younger was a favorable prognostic factor for response, survival, and time to first treatment failure (progression-free survival). Disease Stage IIIA or IIIB, surgery including a bilateral salpingo-oophorectomy plus hysterectomy, and treatment within 6 months of initial diagnosis were favorable predictors for both survival and time to first treatment failure. Ambulatory performance status and well-differentiated disease were favorable prognostic factors for survival. Patients with unevaluable disease failed later than those with evaluable disease who, in turn, failed later than patients with measurable disease.

Adenocarcinoma↗
PubMed1985

Phase II studies of mitoxantrone in patients with primary liver cancer.

Forty-nine patients with histologically confirmed primary liver cancer have been entered on phase II trials of mitoxantrone (Novantrone; dihydroxyanthracenedione), at a dose of 14 mg/m2 every 3 weeks. Among the patients evaluable for toxicity, leukopenia and thrombocytopenia were the most important side-effects encountered. Partial responses have been observed. In a significant number of patients the disease remained stable for at least 1 month. At present the median survival time is, however, only 12 weeks. The response rate and median survival times are similar to those documented with other single cytotoxic drugs, given to comparable groups of patients with primary liver cancer.

Adult↗
PubMed1985

Assessment of ventricular function by radionuclide angiography in patients receiving 4'-epidoxorubicin and mitoxantrone.

Serial assessment of ventricular function by means of radionuclide angiography was performed in 50 patients with malignant neoplasms who received either 4'-epidoxorubicin or mitoxantrone for longer than 3 months. In 9 of 30 patients given 4'-epidoxorubicin, a decrease of greater than or equal to 10% in the left ventricular ejection fraction (LVEF) was documented at doses of 143-1200 mg/m2. Two patients developed clinical signs of cardiotoxicity at a dose of greater than 1000 mg/m2. In 6 of 20 patients given mitoxantrone a decrease of greater than or equal to 10% in the LVEF occurred at doses of 26-98 mg/m2.

Adolescent↗
PubMed1985

A phase II study of bisantrene in advanced refractory breast cancer. An Eastern Cooperative Oncology Group pilot study.

Thirty patients with advanced refractory breast cancer received bisantrene 260 mg/m2 intravenously every 3 weeks. Reversible myelosuppression was the most commonly observed side effect. Four patients (13.3%) achieved objective partial response (90% confidence intervals 3-24%), while two patients (6.6%) had disease improvement with a PR + IMP rate of 19.9%. Seven additional patients (23.3%) had stabilization of disease. This drug has antitumor activity against breast cancer and warrants further study, particularly if problems with drug delivery are overcome.

Adult↗
PubMed1985

Adjuvant CMFP versus CMFP plus tamoxifen versus observation alone in postmenopausal, node-positive breast cancer patients: three-year results of an Eastern Cooperative Oncology Group study.

After mastectomy, 265 postmenopausal patients with node-positive breast cancer were stratified according to pathologic nodal status and estrogen-receptor (ER) status and randomized to receive either 12 cycles of cyclophosphamide, methotrexate, 5-fluorouracil, and prednisone (CMFP), or CMFP plus tamoxifen (CMFPT), or observation alone. Patients entered the study between March 1978 and July 1981. Cox regression analysis indicated that, compared to observation alone, chemotherapy (CMFP and CMFPT groups combined) led to a significant reduction in relapses by the end of the first year of study in every examined prognostic subgroup. However, after the first year the relapse-free survival curves of all treatment groups tended to merge, so that by three years 52% of the observation group and 51% of the chemotherapy groups remained disease free. Chemotherapy continued to show a significantly superior relapse-free survival rate for three years only in the subgroup of patients with ER-negative tumors (the subgroup with the largest relapse-free survival advantage at one year). The addition of tamoxifen produced no benefit or harm in any prognostic subcategory examined. ER status was prognostically important for predicting early relapse only in those patients not receiving chemotherapy, due to the greater effectiveness of this chemotherapy to prevent early relapse in the ER-negative subgroup. Treatment has had no early effect on survival. As breast cancer continues to recur even after ten or more years, later relapse patterns may alter these results.

Antineoplastic Combined Chemotherapy Protocols↗