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Eleven patients with histologically proven cholangiocarcinoma and gallbladder carcinoma were treated with hepatic artery infusion (HAI) of 5-fluorouracil (5-FU) and mitomycin C (Mito-C). Catheters were placed percutaneously through the femoral artery. The schedule used was 5-FU 1200/mg/m2/day given as a continuous infusion for 4 days, plus Mito-C 6 mg/m2 on days 1 and 4. Courses were repeated every 4 weeks. Complete responses (CR) occurred in one patient (9%), and partial response (PR) occurred in six patients (55%). Median survival for all patients from the start of the first treatment was 12.5+ months. Median duration of the response was 3.0 months. Median survival of the patients with gallbladder carcinoma was 12.5 months, and for patients with cholangiocarcinoma has not yet been reached. Drug toxicity was mild, and morbidity of the HAI was minimal. Further trials of chemotherapy in these two neoplasms are warranted.

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Twenty-seven women with disseminated estrogen receptor-negative breast cancer received an aggressive chemotherapy program of prednisone, methotrexate, 5-FU, doxorubicin, and cyclophosphamide. Responses were achieved in 21 of 26 (81%) evaluable patients, eight (31%) of whom had complete responses. The median survival was 17 months. Despite the favorable overall response and a significant number of complete responses, all patients eventually relapsed. Although most patients relapsed systematically, two relapsed initially in the CNS.

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Eleven patients with metastatic thyroid cancer received combination chemotherapy with doxorubicin, bleomycin, vincristine, and melphalan. Six of 11 patients responded, two with a minor response, three a partial, and one with a complete response. Most responses were brief (2-3 months), but the patient with a complete response is alive and free of disease at 60+ months. Toxicity was moderate and predominantly hematologic. Thyroid carcinoma is a moderately sensitive neoplasm with occasional prolonged responses to chemotherapy.

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A patient developed widely metastatic adenoid cystic carcinoma of the parotid gland after several local recurrences. A complete regression of pleural, pulmonary parenchymal, cutaneous, and bone metastases was seen following therapy with 5-fluorouracil, Adriamycin, and mitomycin C. This is the second complete response to chemotherapy reported for a patient with metastatic adenoid cystic carcinoma of salivary gland origin. Both complete responses and several partial responses have followed treatment with Adriamycin, suggesting that this drug is active in the disease.

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Twenty-five patients with unresectable and metastatic pancreatic carcinoma were treated with the combination of 5-fluorouracil, Adriamycin, mitomycin C and streptozotocin (FAM-S). Twelve of 25 patients responded (48%) and four patients demonstrated stable disease. Median survival of all patients was 6.75 months, and seven of 25 patients survived more than 12 months. Hematologic toxicity was moderate, and the predominant side effect recorded was nausea and vomiting (80% patients). Combination chemotherapy in pancreatic carcinoma may provide palliation and randomized trials are warranted to confirm these results.

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To study the toxicity and efficacy of simultaneous cisplatin chemotherapy and radiation therapy, 13 patients with metastatic solid tumors were treated with cisplatin on a weekly, outpatient basis during palliative radiation therapy. The dose of cisplatin ranged from 20 to 50 mg/m2 weekly, with most patients receiving 40 mg/m2. Radiation therapy was administered in a variety of dose-fraction schedules. Toxic effects were moderate and consisted of emesis (12 patients), transient elevation off BUN (three patients), myelosuppression (three patients), and radiation reactions (two patients). Twelve of 13 irradiated lesions (91%) responded with at least a 50% reduction in biperpendicular diameter. Four of the six patients with metastatic melanoma had complete regression of treated lesions; another melanoma patient had a partial response. Responses were also seen in patients with mesothelioma, bladder cancer, squamous cell carcinoma of the head and neck, and oat cell lung cancer. Only one responding patient has had disease progression in the treated field after 2+ to 7+ months of followup; two other patients have died of disseminated disease. Weekly cisplatin administration during radiotherapy deserves further evaluation, especially in the primary management of unresectable tumors that are responsive to cisplatin alone.

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A phase II study study employing 5-fluorouracil, mitomycin C, and streptozotocin in unresectable pancreatic carcinoma was performed. Seven of 22 patients (32%) responded and 4 of 22 (18%) had stable disease. Median survival of the entire group was 6 months, and of responders 9.5 months. In 13 patients with localized disease, five responses (38%) were seen and median survival was 7.5 months. Toxicity of the regimen was moderate, being predominantly gastrointestinal and renal. The usefulness of this regimen in localized pancreatic cancer should be explored further.

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Combination induction chemotherapy consisting of vinblastine, bleomycin, and cis-dichlorodiammineplatinum(II) was administered to 126 patients with advanced germ cell tumors of the testis. Following this 4-month induction therapy, maintenance treatment consisting of chlorambucil and actinomycin D alternating monthly with vinblastine was given for an additional 20-month period. Sixty-four patients (51%) achieved a complete remission, while 33 patients (26%) achieved a partial response. Responses were observed in all histologic categories. Seven patients (11%), who were in complete remission, have relapsed at a median time of 5 months. Median duration of remission is greater than 12 months for complete responders and 4 months for partial responders. Significant leukopenia was noted in 57% of evaluable courses and significant thrombocytopenia was noted in 18%. Less than 20% of patients were noted to have nephrotoxicity. Other toxic effects observed were gastrointestinal (42%), dermatologic (15%), pyrexia (14%), neuromuscular (9%), and pulmonary (less than 5%). Several pretreatment parameters are currently being evaluated to determine the impact on complete remission rate and survival.

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The results of combination chemotherapy with intermittent courses of 5-fluorouracil and streptozotocin in ten patients with metastatic carcinoid tumors and in eight patients with islet cell carcinoma are reported. Objective responses occurred in two of ten and in two of seven evaluable patients respectively. Biochemical responses occurred in an additional two patients with carcinoid. No improvement over single-agent chemotherapy and no effects on survival were noted.

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Piperazinedione was administered in doses of 9 or 12 mg/m2 by iv infusion every 3 weeks in 28 patients with previously treated malignant melanoma. Of the 25 evaluable patients, 72% had drug-induced toxicity: 40% had leukopenia, 56% had thrombocytopenia, 40% had anemia, and 16% had nausea and vomiting. None of these patients had partial remission, two had stable disease, and the remaining 23 had definite progression of their disease in spite of adequate trial with this agent.

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Phase II studies utilizing VP-16-213 in the treatment of 56 patients with malignant lymphoma and 29 patients with malignant melanoma were carried out by the Southwest Oncology Group. All patients had received extensive prior therapy. The initial dose of VP-16-213 administered was 45 mg/m2 by iv infusion over 30-60 minutes on Days 1-5 every 3 weeks but, because, of severe myelosuppression in the lymphoma group, the dose was subsequently reduced to 35 mg/m2. Only three partial regressions lasting 6, 2, and 1 months were noted in 17 patients with Hodgkin's disease. No favorable responses were noted in 35 patients with non-Hodgkin's lymphoma including 16 with the diffuse histiocytic type. No responses were noted in patients with melanoma. The major toxic effect was myelosuppression. VP-16-213 appears to lack significant effectiveness in these previously treated disease.

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