Induction chemotherapy and radiotherapy of advanced cancer of the cervix: a pilot study and phase III randomized trial.

PURPOSE: This study assessed the effectiveness and toxicity of induction chemotherapy (CT) and radiation therapy (RT) in the treatment of locally advanced carcinoma of the cervix with data provided by a pilot study and a randomized trial. METHODS AND MATERIALS: Eighty-six patients with International Federation of Gynecology and Obstetrics (FIGO) Stage IB-IVA (Stage IB >4-cm tumor diameter) (Group A) were entered in a pilot study and treated with cisplatin (50 mg/m2), vincristine (1 mg/m2 on days 1, 11, and 21), bleomycin (25 mg/m2 infusion on days 1-3, 11-13, and 21-23), and standard RT. Ninety-six patients were randomized to either this same CT regimen and RT, or RT alone (Group B: CT plus RT or RT). RESULTS: In Group A, 58% responded to induction CT. With a mean follow-up of 78 months, 73% achieved pelvic control (LRC), and 55% were disease-free survivors. Response to CT was not a marker for ultimate LRC or increased disease-free survival (DFS). In Group B, 62% responded to CT. With a mean follow-up of 43 months, LRC was 68% and 65% for all randomized patients in the CT plus RT and RT arms, respectively (p = NS). In patients who completed treatment, 78% and 70%, respectively, achieved LRC (p = NS). Disease-free survival rates were 38% and 49% for randomized patients in the CT plus RT and RT arms (p = NS), respectively, and 44% and 52% in those patients completing treatment (p = NS), respectively. Complications were acceptable. CONCLUSION: Data from this study did not prove the efficacy of induction CT before definitive RT in locally advanced cancer of the cervix. Induction CT with the currently used combinations and modes of administration should not be considered standard therapy.

A comparison of the onset of action and therapeutic efficacy of amoxapine and amitriptyline.

A total of 61 moderately to severely depressed outpatients were treated for four weeks with either amoxapine (a dibenzoxapine tricyclic) or amitriptyline. This double blind study showed that amoxapine was as effective as amitriptyline and had an earlier onset of action. Maximum doses used were 300 mg of amoxapine and 150 mg of amitriptyline. Side effects were similar for the two drugs, except for impotence or loss of libido in eight male amoxapine, as against three amitriptyline patients. Laboratory, EKG, and vital signs findings showed no pathological trends.

Onset of action of amoxapine and doxepin in outpatients with "mixed anxiety/depression".

In a parallel-group double-blind study, 142 outpatients with "mixed anxiety/depression" were treated with amoxapine or doxepin for 4 weeks in mean maximum daily dosages of 260 mg and 130 mg, respectively. Patients in both groups improved significantly during treatment as shown by changes in the Hamilton, Zung, Patient Self-Evaluation, and Clinical Global Impressions scales. From 24 to 31 of the 71 subjects receiving amoxapine and 16 to 24 of the 71 receiving doxepin were rated as "unquestionably improved" at the end of the treatment period on these scales. The time to achieve this degree of response was significantly shorter with amoxapine on both the CGI (p = .018) and Hamilton (p = .005) scales. Side effects were roughly comparable with two exceptions: doxepin-treated patients experienced more daytime drowsiness (p less than or equal to .05) and amoxapine-treated patients experienced more constipation (p less than or equal to .01).

Some clinical and physiologic effects of a thioxanthene derivative, thiothixene (P-4657B), in 20 newly hospitalized male schizophrenics.

This study was designed to evaluate some of the effects of a new thioxanthene, thiothixene (P-4657B), in 20 male schizophrenic patients recently admitted to Bellevue Hospital. The results of a dosage range trial indicated that at a dosage of approximately 50 mg per day, toxic and side effects as well as therapeutic effects were at their maximum. Parkinsonian reactions (in 17 of 20 patients) with restlessness and akathisia were the most prominent of these effects. Also, activation of psychopathology was observed in six of 20 subjects. Thiothixine did exhibit some antipsychotic activity, but it does not appear to be as valuable as it has been reported to be in chronic schizophrenic patients.