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An 8-year retrospective review of 106 serial computed tomographic (CT) examinations performed on 32 patients with colorectal carcinoma metastatic to the liver was done to determine if the CT appearance of such metastases changed with a favorable response to chemotherapy or with progression of disease. Of these 32 patients, 15 underwent placement of an infusion pump for delivery of chemotherapy directly into the hepatic artery, 3 underwent partial hepatectomy, 1 underwent both procedures, and 13 underwent neither. Regression of hepatic metastases (7 patients), only seen following infusion pump placement, was associated with a decrease in size and an increase in margination of lesions. In two of these patients regression of metastases was seen in one area of the liver with subsequent progression or development of metastases in another region, presumably due to preferential delivery of chemotherapeutic agent. Progression of disease (23 patients) was associated with an increase in both size and number of lesions that became progressively less well marginated. Development of poorly marginated or infiltrative characteristics at the periphery of the lesion was associated with a poor prognosis. Thus, the CT characteristics of hepatic metastases from colorectal carcinoma differ with a favorable response to chemotherapy and with progression of disease.

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The clinical spectrum and the pathological findings of renal toxicity in four patients treated with mitomycin-C are described. Our experience and evidence in the literature indicates that the renal impairment appears to be total-dose-related, with most patients developing renal symptoms after receiving at least 60 mg of mitomycin-C. The renal morphologic changes reveal a glomerular and vascular process similar to that seen in a number of clinical situations associated with the hematologic findings of microangiopathic hemolytic anemia. In patients with malignant disease, it may be that the use of mitomycin-C either alone or in combination with other drugs causes endothelial vascular damage with resultant activation of the coagulation system. There is evidence that early detection of the renal impairment and withdrawal of mitomycin-C might halt further progression of renal failure.

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A clinical picture compatible with the syndrome of inappropriate ADH (antidiuretic hormone) secretion was observed in two patients receiving vinblastine-bleomycin chemotherapy. The mechanism by which this response is brought about is unclear. Penetration of Vinka alkaloids into CSF of humans is poor in the absence of extensive meningeal involvement, and hence an indirect method of action by a reduction in the osmotic threshold for vasopressin release has been suggested. By administering vinblastine on days 1 and 4 (instead of days 1 and 2, as suggested in the high-response regimen consisting of vinblastine, bleomycin, and cis-platinum) we have found better bone marrow tolerance and have not noticed the inappropriate ADH syndrome.

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Advances in methods to diagnose biliary disease have not improved the dismal survival rates reported for primary gallbladder cancer. We analyzed the results of operation in 112 patients with gallbladder cancer. Tumors limited to the gallbladder wall and those that required aggressive surgical therapy and adjuvant chemotherapy for advanced disease were analyzed separately according to the following staging system: tumors that were localized to the mucosa (stage, I, n = 4); tumors that penetrated the muscularis (stage II, n = 4); subserosal tumors (stage III, n = 3); tumors with cystic node involvement (stage IV, n = 13); and tumors that had spread to adjacent organs (stage V, n = 88). Of the 11 patients (10%) with tumor limited to the gallbladder wall (stages I to III), one of five patients (20%) treated with cholecystectomy alone and four of six patients (60%) treated with cholecystectomy and lymphadenectomy (with hepatic wedge resection in three and pancreaticoduodenectomy in one) were alive and tumor free 3 to 6 years after operation. Three patients treated with cholecystectomy alone died of recurrent cancer at 18, 48, and 60 months after operation. Of the 13 patients with cystic node involvement (stage IV), nine were treated by cholecystectomy alone, three with lymphadenectomy, and one with pancreaticoduodenectomy; the cumulative survival rate was only 37% at 6 months, and all patients were dead within 18 months. Of 14 patients with advanced disease (stage V) treated with aggressive surgical therapy, including lymphadenectomy in six patients, hepatic wedge resection in six patients, and right hepatic lobectomy in two patients, the mean survival rate was only 3 months.

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Fanconi's anemia is a rare autosomal recessive disorder which manifests itself in early childhood, presenting as pancytopenia, pigmentation changes, skeletal deformities, small statures and chromosomal aberrations. Most patients ultimately die from sepsis as a result of their hematologic abnormalities, however, some patients live long enough to develop malignancies such as leukemia, hepatocellular carcinomas and squamous cell carcinoma. The association of Fanconi's anemia and squamous cell carcinoma is examined with a report of a patient with Fanconi's anemia and squamous cell carcinoma of the pyriform sinus and hypopharynx.

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We performed what we believe to be the second successful resection of metastatic liposarcoma to the heart using cardiopulmonary bypass. Analysis of ten previous resections of cardiac metastases from a variety of tumors from distant primary sites revealed survivals from four months to two years. When patients can tolerate a major operative procedure, resection of solitary cardiac metastases can be successful if the primary tumor is well controlled. Patients with sarcomas and with long disease-free intervals should strongly be considered for aggressive surgical therapy. Computed tomographic scans of the chest were useful in the diagnosis and accurate delineation of the extent of tumor.

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Despite recent advances in chemotherapy, patients with hepatic metastases treated nonsurgically continue to have a dismal survival rate. Using our experience with surgical resection of pulmonary metastases as a model, we have adopted an aggressive surgical approach to secondary hepatic neoplasms. Hepatic resection for metastatic disease in 64 patients undergoing 75 celiotomies resulted in a cumulative survival rate of 45% at 2 years and 34% at 5 years. Operative procedures included 37 wedge resections, 20 segmentectomies, 16 lobectomies, and 2 total hepatectomies in preparation for liver allograft transplantation. The operative mortality rate (less than 30 days) was significant (20%). The most favorable prognosis was associated with Wilms tumor (4 patients) and colorectal carcinomas (29), the 2-year survivals being 80% and 67%, respectively. Long-term survivors include patients with Wilms (17 and 14 years), leiomyosarcoma (12 years), and colorectal (11 and 10 years) primary tumors. Thirty patients with synchronous resections of the primary tumor and the hepatic resections had 2- and 5-year survival rates of 29% and 26%, whereas 34 patients with metachronous resections had survival rates of 64% and 30%. Eighteen patients underwent resections of multiple hepatic metastases with a survival rate essentially no worse than that of patients with isolated metastases, but careful case selection may have played an important role in the outcome. The extent of hepatic resection was primarily dictated by location and number of metastases. More extensive resections were not associated with a higher long-term survival rate but did have a higher operative mortality. We conclude that an aggressive surgical approach in the treatment of metastatic disease confined to the liver offers a chance for long-term survival and significant palliation in selected patients whose primary tumor is controlled.

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Twelve patients with advanced nodular sclerosis Hodgkin's disease were extensively reassessed following the completion of planned chemotherapy. The evaluation culminated in an exploratory laparotomy. Eight patients with no evidence of abdominal involvement on noninvasive tests also had no Hodgkin's disease found during laparotomy. Four patients had intra-abdominal Hodgkin's disease suspected prior to laparotomy based on the results of the noninvasive procedures. At laparotomy, benign abnormalities were present in three patients; only one had residual Hodgkin's disease. No patient with a negative laparotomy has developed recurrent abdominal Hodgkin's disease, but two patients developed supradiaphragmatic recurrences. The patient with persistent Hodgkin's disease had his treatment regimen successfully altered. These data suggest that patients with negative preoperative findings do not benefit further from a laparotomy. However, in selected patients with suspicious intra-abdominal findings, the results of laparotomy may alter future management.

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A prospectively randomized study of postoperative chemotherapy with dimethyl triazeno imidazole carboxamide (DTIC) was conducted by the Central Oncology Group from 1972 until 1976. Of 174 patients operated upon for melanoma and entered into the study, 87 were randomly selected to receive DTIC, four courses in 12 months, at 4.5 mg/kg/d x 10. One-hundred-sixty-five (95%) of the cases were evaluable, including 40 high risk Stage I, 96 Stage II, and 29 Stage III cases. At a median follow-up period of 2.5 years, the control group had a better median disease-free interval (40 weeks vs. 73 weeks), median survival time (103 weeks vs. 133 weeks), and percentage of patients living free of disease (28% vs. 44%) than the DTIC-treated group. While disease-free interval appeared to be improved in the 25% of patients on DTIC therapy who developed thrombocytopenia, the overall effect of postoperative DTIC therapy was apparently not beneficial (P less than 0.05).

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Pulmonary resection for metastatic disease in 167 patients undergoing 207 thoracotomies resulted in a cumulative survival rate of 29% at five years and 20% at 10 years, with an operative mortality of 0.6%. The most favorable prognosis was associated with testicular and renal cell carcinomas and sarcomas. Less favorable tumors were malignant melanoma, carcinoma of the colon and rectum, and cervix uteri. A significant factor influencing survival was duration of disease-free interval with a 50% five-year survival rate in patients whose primary tumor was treated over five year ago. Patients with multiple pulmonary metastases had a five-year survival rate of 27% vs. 22% of patients with solitary metastases. Of 23 patients with tumor extending to the chest wall, diaphragm, or pleura, only two survived five years. Of 26 patients with mediastinal involvement none survived two years.

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Intraarterial infusion chemotherapy has several theoretical advantage over conventional therapy for the treatment of unresectable malignancies. However, the catheter problems and patient restriction to the hospital associated with its use have resulted in infrequent application and a notable lack of progress in this field of oncology. This paper describes the use of a totally implantable, percutaneously refillable infusion pump in 5 patients with primary or metastatic carcinoma of the liver. The infusion cannulae were placed into the hepatic arteries under direct vision at laparotomy, and the pumps were placed in subcutaneous pockets. Four patients received infusions of 5-fluorodeoxyuridine at rates of 0.2-0.5 mg/kg/day for periods of three to 29 weeks; the pump in the fifth patient was defective and was removed. The implanted pumps were well tolerated in these subjects, who received chemotherapy as outpatients; the only adverse effects noted were related to FUDR toxicity. This implantable infusion pump appears to be a practical means of delivering long-term intraarterial infusion chemotherapy to outpatients.

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In a controlled, prospectively randomized trial, 74 patients with hepatic metastases from colorectal cancer were randomized to either intra-arterial hepatic artery infusion with 5-fluorouracil (5-FU) or systemic chemotherapy with 5-FU. In 61 acceptable patients, there was no significant difference in terms of response rate, time to progression, duration of the response, and survival rate. Though the response rate for the intra-arterial infusion arm was slightly higher than for the systemic arm, the difference was not significant, and the intra-arterial infusion arm was associated with a greater incidence of nausea, vomiting, diarrhea, in addition to complications of femoral-arterial thrombosis, bleeding, and infection at the catheter site not seen in patients treated by systemic chemotherapy. Patients with an objective response to chemotherapy on either treatment arm survived twice as long as the nonresponders. Long-term survival in one patient, 77 months, can occasionally be achieved in patients with hepatic metastases.

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A vaccine made of irradiated Vibrio cholerae neuroaminidase (VCN) treated autochthonous tumor cells plus BCG was utilized in combination with surgery or with chemotherapy for Stage II and Stage III malignant melanoma, respectively. A few patients with Stage I melanoma were treated with surgery and BCG. Most of the studies were carried out on a prospective, randomized protocol. When the results with conventional therapy were compared with the results of conventional therapy plus immunotherapy, no beneficial effects of the immunotherapy were seen. Stratification insured comparability in both immunotherapy and nonimmunotherapy groups. We conclude that VCN treated tumor cells plus BCG, when administered according to the protocol utilized here, offer patients with malignant melanoma no substantial benefit when compared with conventional therapy.

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From May 1972 until May 1976, 105 patients were entered on Central Oncology Group protocol 7230 to compare the combination of streptozotocin, tubercidin, and 5-fluorouracil (5-FU) versus 5-FU alone in the treatment of adenocarcinoma and islet cell carcinoma of the pancreas. Twenty-nine were not evaluable. Thirty-six evaluable cases received 5-FU, and 40 received the combination, with no significant difference in time to progression or survival. Toxicity in the two regimens was somewhat different but was essentially similar in magnitude. Results indicate no benefit in the treatment of adenocarcinoma of the pancreas with the three-drug combination over 5-FU alone. All of the islet cell tumor patients benefited from the combination by response or arrest of progression of disease. Further study should be directed toward the use of this combination in the treatment of functioning and non-functioning islet cell tumors of the pancreas.

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Fifty patients with melanoma (30 with clinical Stage I disease and 20 with clinical Stage II disease) were analyzed retrospectively along with the screening test done prior to surgery. While the value of the chest X ray is unquestioned in preoperative screening, the same cannot be said of liver, brain, and bone scans. The bone marrow biopsy, however, done with a Janshidi needle was of value in detecting one patient with bone-marrow metastases who on examination had clinical Stage II disease and precluded surgery in this same individual. Therefore, we feel that in the preoperative scanning of patients with Stage I or Stage II human malignant melanoma, and especially in the latter, the bone-marrow biopsy should be done routinely in addition to a hematological profile, liver profile, and chest X ray.

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Thirty-one patients with Stage I melanoma were studied with regard to their response to common skin antigens. Patients were divided into two groups, those who had surgery alone, and those who had surgery and BCG. The results were comparable. It was found that the disease-free interval was longer and the recurrence rate lower in patients who demonstrated cutaneous hypersensitivity to common antigens than in those who did not. Patients who had Clark's levels I and II lesions were more likely to be immunocompetent. The addition of BCG in the study did not appear to decrease the rate of recurrence, which seems to be related to the basic immunological status of the individual.

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