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Biomedical subjects

G Falkson

Publications and source records attributed to G Falkson.

At least 109 records · Page 6Linked to original sources
PubMed1989

Ifosfamide in advanced carcinoma of the esophagus: a phase II trial with severe toxicity.

Seventeen patients with advanced epidermoid carcinoma of the esophagus were treated with ifosfamide (IFOS) 1.5 mg/m2/day intravenously on days 1-5 every 28 days. Mesna was given concurrently at 20% of the IFOS dose prior to and 4 and 8 h after IFOS for uroprotection. Toxicity in this trial was severe since life-threatening leukopenia occurred in one patient, Grade 3 nausea and vomiting (necessitating termination of treatment) in two patients, and Grade 3 neurotoxicity (cerebellar dysfunction) in two patients. Two patients developed severe infections (Grade 3). Only four patients experienced no toxicity. One patient had a partial response with a response duration of 8 weeks. The median survival of all patients is 10 weeks. It is concluded that IFOS as given in this trial has limited activity in esophagus carcinoma with severe toxicity.

Carcinoma, Squamous Cell↗
PubMed1989

Normalization of skin appearance in a patient with scleromyxoedema after intensive chemotherapy for Hodgkin's disease.

A patient with scleromyxoedema was treated for 6 years with cytostatic drugs. During this time the skin lesions followed a fluctuating but progressive course. After 6 years she developed Hodgkin's lymphoma of the mixed cellularity type. Intensive cytostatic treatment given for Hodgkin's disease resulted in virtually complete disappearance of the scleromyxoedema lesions. The development of Hodgkin's disease is considered fortuitous and not due to the previous cytostatic drugs.

Adult↗
PubMed1989

Six-year results of the Eastern Cooperative Oncology Group trial of observation versus CMFP versus CMFPT in postmenopausal patients with node-positive breast cancer.

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.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1989

Myelodysplastic syndrome and acute nonlymphocytic leukemia secondary to mitolactol treatment in patients with breast cancer.

One thousand four hundred sixty patients with 2,590 patient-years of follow-up were treated on 15 protocols for metastatic breast cancer with dibromodulcitol (mitolactol; DBD)-containing regimens since 1976. Twenty-three patients developed myelodysplastic syndrome (MDS) and/or acute nonlymphocytic leukemia (ANLL). The overall risk of developing MDS or ANLL per person is 1.6%. In patients who had received more than 16,000 mg of DBD the risk per person is 6%, and in the high-dose subsets of patients who received no prior radiation or alkylator therapy, it is 7.9%. The risk per person increases to a maximum by 30 to 36 months (5.3%). The high risk was seen despite a study population of metastatic breast cancer patients with a median survival of 16 months. This analysis strongly suggests that DBD is one of the most potent of the reported leukemogenic-inducing agents. Further use of this drug in both the adjuvant and metastatic situation should be reconsidered.

Adult↗
PubMed1988

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↗
PubMed1988

Radionuclide angiographic monitoring in patients treated with potentially cardiotoxic cytostatic drugs.

A prospective study of 120 patients with cancer was carried out to evaluate the effects of potentially cardiotoxic anticancer drugs using radionuclide cardiovascular studies. Five groups were studied: 7 patients received 4'-demethoxydaunorubicin, 23 4'-deoxydoxorubicin, 34 4'-epidoxorubicin, 49 mitoxantrone and 7 4'-(9-acridinylamino)-methan-sulphon-m-anisidide (amsa). Two patients receiving 4'-demethoxydaunorubicin, 7 on 4'-deoxydoxorubicin, 11 on 4'-epidoxorubicin, 21 on mitoxantrone and 3 on amsa had falls of greater than or equal to 10% in their left ventricular ejection fraction. Using data from this study, the recommended guidelines are set out.

Amsacrine↗
PubMed1988

Rapid reversal of life-threatening hypoglycaemia with a somatostatin analogue (octreotide). A case report.

A patient with life-threatening hypoglycaemia caused by metastatic malignant insulinoma is described. Treatment with octreotide (SMS 201-995, Sandostatin; Sandoz) resulted in immediate sustained improvement of the hypoglycaemia despite persistent high levels of insulin. The possible mechanisms of action, other indications and contraindications of octreotide are discussed.

Adenoma, Islet Cell↗
PubMed1988

Trimetrexate in advanced carcinoma of the esophagus.

Twenty-four patients with advanced epidermoid carcinoma of the esophagus were treated with trimetrexate (TMTX), a lipid soluble non-classical antifol. Patients were given TMTX 8 mg/m2 intravenously day 1-5 every 28 days. In nine of these patients the dose was escalated to 12 mg/m2 day 1-5 every 28 days. Three patients had a partial response (95% confidence limit 3-32%) with a median response duration of 14 weeks. No hematologic toxicity was documented. Two patients developed moderate stomatitis and only 3 patients experienced any nausea or vomiting. The median survival of all patients is 12 weeks. It is concluded that a higher dose of TMTX should be studied in patients with esophageal cancer in order to assess the true therapeutic value of the agent at a dose closer to the median tolerated dose. A phase II ECOG study using TMTX 12 mg/m2 intravenously day 1-5 every 21 days is currently being conducted.

Carcinoma, Squamous Cell↗
PubMed1988

The prognostic significance of age in patients with advanced Hodgkin's disease.

One hundred and forty-eight patients with Stage III and IV Hodgkin's disease, treated at a single institution, were studied to investigate the importance of age as a prognostic pre-study factor. The median age of the patients was 30 (2-81). All patients received combination chemotherapy. The overall response rate was 85%. The median survival is not reached with a median follow-up time of 9.6 years. Age was found to be the dominant prognostic discriminant with younger patients having a better survival. Factors which were significant in a univariate analysis were performance status (PS), stage, weight loss, histology and liver involvement. In a stepwise logistic regression model, however, only age and PS remained independent significant prognostic discriminants. It is concluded that even in the absence of serious concomitant disease, such as heart disease, age is the single most important prognostic variable.

Adolescent↗
PubMed1988

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↗
PubMed1988

A phase II evaluation of combination chemotherapy plus aminoglutethimide in women with metastatic or recurrent breast carcinoma. An Eastern Cooperative Oncology Group Pilot Study.

The Eastern Cooperative Oncology Group (ECOG) conducted a pilot study of combination chemotherapy with cyclophosphamide, doxorubicin, and 5-fluorouracil plus aminoglutethimide (250 mg three times daily with hydrocortisone supplementation of 40 mg daily) as primary therapy for estrogen receptor-positive or unknown advanced breast carcinoma to assess whether these agents can be safely combined and to provide a preliminary estimate of response rate. A total of 47 patients, 45 with metastatic breast cancer and two with stage IV disease who were rendered clinically disease free following surgical resection of chest wall recurrence, were treated. Leukopenia and mucositis were the most frequent toxicities requiring dose reduction, but only five patients (10.6%; 95% confidence interval, 1.8-18.4%) experienced life-threatening leukopenia (less than 1000/mm3) at some point during their therapy. Neurologic side effects attributed to aminoglutethimide, predominantly lethargy, were reported in less than one-third of patients, and rarely required dose reduction. One elderly patient developed clinical hypothyroidism during the first 3 months on therapy and experienced a cardiac arrest at home while receiving supplemental thyroid hormones. The overall complete plus partial response rate in 45 patients was 55.5% (95% confidence interval, 41-70%). Among 16 patients with measurable disease, the complete plus partial response rate was 75% (95% confidence interval, 54-96%). The complete plus partial response rate in 29 patients with nonmeasurable but evaluable disease was 45% (95% confidence interval, 27-63%) and an additional 14% had improvement in bone pain. Eight patients electively discontinued chemotherapy after 7-24 months of therapy, but continued aminoglutethimide. The median time to disease progression is 462 days (15.4 months); 25% of patients died by 552 days (18.4 months), and the median duration of survival is predicted to be 889 days (29.6 months). We conclude that aminoglutethimide can be combined with this doxorubicin-based regimen with acceptable toxicity and an overall response rate which is similar to that observed on prior ECOG trials with cyclophosphamide, doxorubicin, and 5-fluorouracil.

Adult↗
PubMed1988

ECOG phase II trials of MGBG, chlorozotocin, COM multidrug therapy in advanced measurable colorectal cancer.

The Eastern Cooperative Oncology Group (ECOG) entered 326 patients with advanced measurable colorectal cancer into four phase II drug or drug combination trials. Previously treated and chemotherapy-naive patients were eligible. Chlorozotocin was administered to 83 patients (51 previously treated), methyl-glyoxal-bis-guanylhydrozone (MGBG) to 90 patients (58 previously treated), and two regimens of the three-drug combination of cyclophosphamide, vincristine, and methotrexate (COM) to 153 patients (120 previously treated). The multidrug regimen had been developed specifically for previously treated patients. In this trial, chemotherapy-naive patients were no more likely to respond than were members of the previously-treated group. Even among previously untreated patients, response rates did not exceed 10% in any of these phase II programs. They are not recommended for further trials in patients with colorectal cancers.

Adenocarcinoma↗
PubMed1988

Cyclophosphamide, mitoxantrone, vincristine and prednisone in the treatment of non-Hodgkin's lymphoma.

Twenty-two patients with histologically confirmed non-Hodgkin's lymphoma received treatment with a chemotherapy combination containing cyclophosphamide, mitoxantrone, vincristine and prednisone. Leukopenia, nausea and vomiting were the most common side effects. A response rate of 77% (17 of 22 patients) was documented. These results indicate that the four-drug combination including mitoxantrone has good therapeutic activity in the treatment of non-Hodgkin's lymphoma.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1988

Malignant pleural mesothelioma: a disease unaffected by current therapeutic maneuvers.

From 1965 to 1985, 262 patients with malignant pleural mesothelioma were treated with cytostatics only; radiotherapy (RT); RT and cytostatics; or decortication plus RT plus cytostatics. The median survival (MS) from diagnosis was 9.6 months. This was similar for all comparable treatment groups. In a univariate analysis, significant favorable prognostic factors were good performance status (PS), duration of symptoms greater than 6 months at the time of diagnosis, early stage of disease, white race, and female sex. In a multivariate analysis, PS, race, duration of symptoms, and stage were of significance for a favorable prognosis. Age, pain as first symptom, histologic subtype, and RT dose were not of prognosis significance in this study. The stepwise addition of treatment modalities did not increase survival, which remained the same as that reported for untreated patients. Therefore, phase II trials of new agents offer the only hope for advance in the treatment of this disease.

Adult↗
PubMed1987

A random phase II study of mitoxantrone and cisplatin in patients with hepatocellular carcinoma. An ECOG study.

Of 86 patients entered in an Eastern Cooperative Oncology Group (ECOG) random Phase II study of mitoxantrone (DHAD) and cisplatin (DDP) in primary liver cancer, 69 were eligible. Nine of the 13 ineligible patients were excluded after a pathology review. Sixty-one percent of the patients were North American, and 39% were South African. The most common severe or the worst toxicity on DHAD was hematologic; and to DDP, hematologic and vomiting. Of the 69 eligible patients, 21 experienced severe, life-threatening or fatal toxic reactions. Two patients treated with DDP had partial responses. With a 95% confidence interval, the true response rate to DHAD was less than 8%, and to DDP, less than 17%. The median survival time was 14 weeks on both drugs. Assuming a proportional hazards model, factors that are significantly associated with survival are patient performance status, the presence of the symptoms, raised bilirubin and hepatomegaly, and clinical evidence of cirrhosis. Any differences between survival rates for South African and North American patients were largely explainable by these factors.

Antineoplastic Combined Chemotherapy Protocols↗