Comparison of conventional dose and double dose carboplatin in patients receiving cyclophosphamide plus carboplatin for advanced ovarian carcinoma: a North Central Cancer Treatment Group Study.

Between March 1992 and November 1994, 91 patients with stage III and IV ovarian carcinoma were enrolled in a randomized comparative study of cyclophosphamide 600 mg/m2 plus carboplatin 300 mg/m2 vs. cyclophosphamide 600 mg/m2 plus carboplatin 600 mg/m2, each regimen given monthly for six cycles. Patients on the intensive regimen also received 10 micrograms/kg of granulocyte macrophage colony stimulating factor (GM-CSF) (molgramostim) daily for 14 days following each chemotherapy treatment. The study was closed prematurely because of very poor case accrual following the preliminary announcement (in May 1993) that paclitaxel appeared superior to cyclophosphamide in the platinum-based treatment of ovarian cancer. More than 4 years after our last case entry, we analyzed the survival results for the 44 eligible patients who received the conventional dose of carboplatin and the 43 eligible patients receiving our intensified dose of carboplatin. More than 90% of the treated patients receiving the conventional dose regimen received at least 75% of the planned doses at each of the six treatment intervals, whereas the percentage of treated patients able to receive at least 75% of the assigned intensive dose regimen had declined from 95% in cycle 2 to 53% by cycle 6. Furthermore, although 32 patients received all six planned cycles of treatment in the conventional regimen group, only 15 received all six cycles of the intensified regimen. Patients receiving the intensive regimen had more fever, dermatitis, lethargy, musculoskeletal pain, and pulmonary complications than did the conventional dose patients. Median survival times for the two treatment groups were very similar (38.5 and 38.1 months, respectively, for the conventional and intensive regimens), and we saw no evidence that the distribution of survival times differed between the treatment regimens (p = 0.95).

Breast cancer and pregnancy.

Breast cancer occurring during pregnancy is a relatively rare clinical situation that may present many difficult medical and psychosocial problems. Its diagnosis is commonly delayed, largely related to breast changes which normally occur during pregnancy. When matched for age and stage of disease, patients with breast cancer during pregnancy have the same prognosis as nonpregnant patients; the disease stage at diagnosis is the most important predictor of survival. Breast cancer diagnosed during pregnancy should be treated according to the same principles applied in nonpregnant patients. Termination of pregnancy does not appear to improve survival and thus, decisions regarding termination of pregnancy should be based on the desires of the patient, along with the urgency for radiation or chemotherapy that could potentially be harmful to the fetus. Subsequent pregnancy following the diagnosis of breast cancer does not have a known detrimental effect on survival, although it is usually wise to discourage pregnancy for the first few years following the diagnosis of breast cancer.

Effect of elective induction on birth weight.

The 1,250 Mayo Clinic obstetric deliveries for 1976 were reviewed and 73 elective inductions were identified. Sixty-three of these mothers were successfully matched by gravidity, parity, and age within 5 years with healthy women in whom delivery was spontaneous at term. The mean birth weight for the electively delivered infants was greater than that for the controls, but the difference was not statistically significant. Mean gestation and 1-minute Apgar scores were similar for both groups. The neonatal problems observed, with the exception of elevated bilirubin levels, did not seem to point to any special hazard of induction. Even though pregnancy is interrupted, elective induction, as practiced at the Mayo Clinic, was not shown to produce a systematic reduction in birth weight.