ABSTRACT
After a 26% response rate was reported with a 20/mg/m2/week vinorelbine (VRL) dose, a multicenter phase II trial of a modified weekly VRL treatment protocol (30 mg/m2 days 1 and 8 every 21 days) for unresectable non-small cell lung cancer (NSCLC) was designed to determine its clinical activity, toxicity, and survival of treated patients. As myelotoxicity frequently precludes the administration of VRL, by suppressing the dose that would correspond to day 15 of a weekly protocol, we allowed bone marrow recovery to take place and avoided the administration of the drug at the nadir of the cycle. The trial included 71 consecutive, previously untreated patients with unresectable and measurable disease. A total of 297 three-week treatment courses were administered with an average of 4 courses per patient (range 1-11). Results showed that in spite of attaining a median dose intensity of 19 mg/m2/week, this modified weekly VRL treatment regimen has a low level of activity (7.5% response rate) in NSCLC. Although a more tolerable level of toxicity is achieved, in order to maintain its antitumor activity, the recommended dose of VRL when given alone for NSCLC treatment (30 mg/m2/weekly) should not be decreased.
Subject(s)
Antineoplastic Agents, Phytogenic/administration & dosage , Carcinoma, Non-Small-Cell Lung/drug therapy , Lung Neoplasms/drug therapy , Vinblastine/analogs & derivatives , Adult , Aged , Antineoplastic Agents, Phytogenic/toxicity , Carcinoma, Non-Small-Cell Lung/mortality , Female , Humans , Lung Neoplasms/mortality , Male , Middle Aged , Survival Rate , Vinblastine/administration & dosage , Vinblastine/toxicity , VinorelbineSubject(s)
Abnormalities, Drug-Induced/etiology , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Clubfoot/chemically induced , Hand Deformities, Congenital , Pregnancy Complications, Neoplastic/drug therapy , Sarcoma, Ewing/drug therapy , Spinal Neoplasms/drug therapy , Adolescent , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Cyclophosphamide/administration & dosage , Cyclophosphamide/adverse effects , Doxorubicin/administration & dosage , Doxorubicin/adverse effects , Female , Humans , Infant, Newborn , Male , Pregnancy , Vincristine/administration & dosage , Vincristine/adverse effectsABSTRACT
Acute leukemia was diagnosed in five pregnant patients who received chemotherapy during the course of pregnancy. Three were undergoing chemotherapy at conception. One patient died in the fifth month of pregnancy and the anatomic study of the fetus was normal. Four babies had low birth weights at birth. Of the four one was born prematurely, but without malformations. Later development was normal. The results are reviewed and compared with data from the literature, leading to the conclusion that pregnancy is not an absolute contraindication for cytostatic treatment, except in the first trimester, in which cytostatic treatment should be avoided.
