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Background. In a Phase II trial, surgical adjuvant active specific immunotherapy using a live vaccinia virus-augmented allogeneic polyvalent melanoma cell lysate, vaccinia melanoma oncolysate (VMO), produced a significant disease free interval (DFI) in patients with International Union Against Cancer Stage II melanoma with positive lymph nodes. Therefore, a Phase III randomized prospective, double-blind, multiinstitutional, surgical adjuvant VMO trial was performed to determine the efficacy of VMO to increase the DFI and the overall survival in this group of patients with Stage II disease. Methods. Two hundred and fifty patients with Stage II melanoma were divided into two postsurgical groups. One group received VMO (total protein equals 2 mg/ml) and the other received the placebo of live vaccinia vaccine virus (V) (10[sup 5.4] TCID[sub.50/ml], an adjuvant component of the VMO. Patients initially received these biologics once a week for 13 weeks and then once every 2 weeks for an additional 39 weeks or until recurrence. All surviving patients have been followed for at least 30 months. Results. Statistical analysis of survival data (n = 217) for this first interim analysis shows that there is no statistically significant (P = 0.99) increase in DFI of patients treated with VMO (n = 104) when compared with V (n = 113). The median DFI is 38.0 months for patients treated with VMO and 37.0 months for patients treated with V. At 2- and 4-year intervals, 70 and 38%, respectively, of patients treated with VMO vs. 66 and 36%, respectively, of patients treated with V were free of melanoma. The median overall survival is not available because the patients treated with VMO have not yet reached the 50% mark and the median overall survival is 45.0 months for patients treated with V. At 2- and 4-year intervals, 70 and 38%, respectively, of VMO-treated patients survived when compared with 66 and 36%, respectively, of patients treated with V. Although the overall survival of patients treated with VMO is not statistically significant (P = .88) at this point, there is an increasing trend in the overall survival of patients treated with VMO; a 10% increase at the 4-year time point. Moreover, in the subset analysis, VMO-treated male patients (n = 63) showed a 17% improvement in survival at 4-year time point when compared with male patients treated with V (n = 67) (P = 0.19) at the same time point and male patients (n = 20) between the ages of 44 and 57 having 1-5 positive lymph nodes showed a 37% difference in overall survival at the 4-year time point when compared with those patients treated with V (n = 18) (P = 0.13) at the same time point. Conclusion. In this first interim analysis, active specific immunotherapy with VMO vs. V showed no difference in the disease free interval or overall survival. Subset analyses likewise showed no significant differences in outcome but the data suggest a potential difference in immunoreactivity between male and female patients with melanoma that awaits further follow up and may merit further investigation.

Background. In 1978, the National Prostatic Cancer Project launched two protocols evaluating adjuvant therapy after surgery (Protocol 900) or irradiation (Protocol 1000) for clinically localized prostate cancer. All patients underwent staging pelvic lymphadenectomy. Methods. After definitive treatment, the patients were randomized either to receive cyclophosphamide 1 g/[m.sup.2] intravenously every 3 weeks for 2 years or estramustine phosphate 600 mg/[m.sup.2] orally daily for up to 2 years or to undergo observation only. Patient accession closed in 1985 and includes 184 patients in Protocol 900 (170 evaluable) and 253 in Protocol 1000 (233 evaluable). Results. Lymph node involvement was identified in 198 patients (49% of total), 29% in Protocol 900 and 63% in Protocol 1000. The median progression-free survival (PFS) and survival were greater for patients in Protocol 900 compared with 1000, regardless of the adjuvant therapy. This reflected the greater proportion of patients with lower pathologic stage disease in the surgically treated group. The median PFS was significantly greater for all patients in Protocol 1000 receiving estramustine phosphate adjuvant (48.2 months) compared with patients randomized to receive cyclophosphamide (35.6 months). The median PFS for patients with nodal involvement in Protocol 1000 who received estramustine phosphate adjuvant was prolonged significantly (37.3 months) compared with no treatment (20.9 months). The median PFS for patients with limited nodal disease in Protocol 1000 was longer (39.9 months), regardless of the adjuvant therapy, compared with those with extensive nodal disease (20.7 months). However, in the latter patient group, those receiving adjuvant estramustine phosphate had a significantly longer median PFS (32.8 months) compared with those receiving adjuvant cyclophosphamide (22.7 months) or no adjuvant therapy (12.9 months). Conclusion. Adjuvant estramustine phosphate was beneficial in patients with prostate cancer and pelvic node involvement who received irradiation as definitive treatment. Cancer 1993; 71:1005-13.

The researchers of the National Prostatic Cancer Treatment Group have followed 212 patients with confirmed stage D-1 prostatic cancer. Fifty-one of these patients were treated with surgery, and 161 with radiotherapy. All patients received some sort of adjuvant chemotherapy. The anatomical locations of involved lymph nodes were tabulated to discover if this information has prognostic value. There has been some controversy regarding the involvement of lymph nodes and the prognosis of prostate cancer; in the present study the involvement of fewer than 20 percent of the examined nodes had a significantly better prognosis than did the involvement of more than 20 percent. It is worth noting that if the data are examined in terms of actual number of nodes involved, there is no prognostic value. That is, if the involvement of one to three nodes is compared with the involvement of more than 3, there is no significant difference in the survival. The data gave no indication that the location of the involved lymph nodes was of any prognostic value. (Consumer Summary produced by Reliance Medical Information, Inc.)

Combination chemotherapy appears superior to single‐agent therapy in treating a wide variety of tumors. Encouraged by this data, we conducted a pilot study using cyclophosphamide, adriamycin, intermediate dose methotrexate and folinic acid rescue (CAMF) in patients with advanced lung cancer. Forty‐eight patients with unresectable tumors were entered on this trial, and treated with 500 mg/m2intravenously administered cyclophosphamide, 50 mg/m2intravenously administered adriamycin, 40 – 200 mg/m2orally administered methotrexate (4 doses/24 hrs), and 5 mg orally administered folinic acid (6 doses/36 hrs); this regimen was repeated every three weeks if tolerable. There were 43 patients evaluable for toxicity and 34 (non‐small cell types) for response. The major toxicities were myelosup‐pression and nausea and vomiting. The overall response rate (complete and partial responses) was 29.4% (10/34) and in 13 patients (38%), the disease was stabilized. Those responding had a median survival time of 10.5 months versus 4 months for nonresponders. Patients in whom the disease was stabilized had a median survival time of 8 months. CAMF is a well‐tolerated drug combination with promising results in patients with advanced lung cancer.