The Southwest Oncology Group analyzed outcome with cytotoxic chemotherapy for previously untreated acute myeloblastic leukemia (AML) from 1982 through 1986. Results with acute promyelocytic leukemia (APL) prompted comparison with patients from 1986 through 1991 and analysis of factors contributing to APL results. Patient and disease characteristics and treatment outcome were compared for all evaluable patients, with more detailed analysis of factors affecting APL treatment outcome. From 1982 through 1986, median survival and disease-free survival in 45 APL patients were 106 months and greater than 105 months, respectively, versus 6 and 14 months for 417 other AML patients. Such differences were not seen from 1986 through 1991. In the 141 APL patients from 1982 through 1991, after adjusting for significant patient and disease characteristics, higher daunomycin (DNR) doses during induction were significantly associated with higher complete remission rates (P < .0001), longer survival (P < .0001), and longer DFS (P < .0001). Cytosine arabinoside (Ara-C) induction dose, the inclusion of other chemotherapy agents in induction, postremission therapy (consolidation, maintenance, or bone marrow transplantation) other than DNR, APL subtype, and patient age did not appear to significantly affect outcome of APL, except for a significant detrimental effect of high-dose Ara-C in consolidation (P = .0042). Morphologic AML subtypes other than APL did not affect outcome. We conclude that high-dose DNR selectively increases survival in APL. This good survival is important for evaluation of combined all-trans retinoic acid (ATRA)/chemotherapy protocols and for planning future combinations of chemotherapy and ATRA. These results illustrate the need to individualize chemotherapy for subtypes of AML. Therapeutic response of APL is independent of age. Except for APL, morphologic subclassification of AML contributed little prognostic information.

The Southwest Oncology Group tested three combinations of drugs with Adriamycin to identify a best regimen for treatment of advanced breast cancer. Adriamycin, cyclophosphamide, and 5-fluorouracil (5FU)(FAC); Adriamycin and cyclosphosphamide (AC); and Adriamycin followed by cyclophosphamide, vincristine, methotrexate, 5FU, and prednisone (A + COMFP) were used in a prospective randomized study of 497 patients with previously untreated metastatic breast cancer. The complete response (CR) plus partial response (PR) was (57/140) 44% with AC, (77/160) 48% with FAC, and (78/148) 46% with A + COMFP. The median length of response was 29, 52, and 37 weeks respectively, with AC, FAC and A + COMFP. The median survival of all patients was 79 weeks; 89 weeks AC, 84 weeks FAC, and 76 weeks with A + COMFP. Toxicity was similar in all three regimens except that leukopenia was more common with FAC.

Rubidazone, a new anthracycline antibiotic, is the benzoyl hydrazone derivative of daunorubicin. The Southwest Oncology Group carried out a phase II study of the drug in 126 patients with previously treated acute leukemia; 116 patients were evaluable. Good-risk patients were given doses of 450 mg/m2, and poor-risk patients were given doses of 300 mg/m2 approximately every 3 weeks. No complete response was observed in 25 patients with chronic myelocytic leukemia blast cell transformation. In the remaining patients the overall complete response rate was 22% and the rate of complete plus partial response was 29%. In good-risk patients these rates were 27% and 35%, respectively. Toxicity was similar to that observed with other anthracyclines except that acute febrile reactions were more pronounced. On the basis of the results, there are plans for a large-scale comparison study of rubidazone versus doxorubicin, each in combination with cytarabine, vincristine, and prednisone.

From November 1976 to November 1978, the Southwest Oncology Group treated 254 patients with extensive (metastatic) small cell carcinoma of the lung with combination chemotherapy and radiotherapy with and without BCG immunotherapy. Patients receiving BCG achieved a response rate of 50% versus those patients not receiving BCG of 46% (P = .704). Response duration was 20 weeks for the BCG arms and 23 weeks for the no-BCG arms; survival was 28 weeks for the BCG arms versus 29 weeks for the no-BCG arms. An adverse effect in patients surviving more than one year was detected; those continuing to receive BCG had significantly shorter survival, 60 weeks versus 85 weeks (P = .019). Toxicities of the programs were not affected by the addition of BCG immunotherapy. It appears that BCG immunotherapy has no beneficial effect on response rate or duration of response in programs using chemotherapy and radiotherapy for control of metastatic small cell carcinoma of the lung. In addition, because of the adverse effect on long-term survival, we do not recommend the addition of BCG immunotherapy as a treatment modality in this tumor type.

We have studied a 41-year-old black male with the simultaneous occurrence of hereditary persistence of fetal hemoglobin (HPFH) and beta-thalassemia, and his two postadolescent sons, each heterozygous for one of the traits. The son heterozygous for beta-thalassemia had an elevated Hb A2, but the index case did not. The data from this pedigree indicate that the delta-allele trans to the beta-thalassemia gene was reponsible for the increased delta-chain production. Evidence from other cases of combination HPFH and beta-thalassemia indicates that regulation of the beta- and delta-chain production in beta-thalassemia is heterogeneous with respect to mechanism.

We have studied a 41-year-old black male with the simultaneous occurrence of hereditary persistence of fetal hemoglobin (HPFH) and beta-thalassemia, and his two postadolescent sons, each heterozygous for one of the traits. The son heterozygous for beta-thalassemia had an elevated Hb A2, but the index case did not. The data from this pedigree indicate that the delta-allele trans to the beta-thalassemia gene was reponsible for the increased delta-chain production. Evidence from other cases of combination HPFH and beta-thalassemia indicates that regulation of the beta- and delta-chain production in beta-thalassemia is heterogeneous with respect to mechanism.