Paclitaxel and carboplatin adjuvant therapy alone or with radiotherapy forresected nonsmall cell lung carcinoma - A feasibility study of the Minnie Pearl Cancer Research Network

Background. The objective of this study was to determine the feasibility an d toxicity of paclitaxel and carboplatin given in the adjuvant setting alon e for patients with resected Stage IB disease and combined with radiotherap y for patients with resected Stages II and IIIA disease and selected patien ts with Stage IIIB and IV disease (Revised International System for Staging of Lung Cancer). Methods. One hundred two patients with resected nonsmall cell lung carcinom a were treated in the postoperative period with 3 courses of paclitaxel 200 mg/m(2) intravenously (i.v.) over 1 hour and carboplatin area under the cu rve of 6 i.v. every 3 weeks for 3 courses. Patients with Stage IB received no further therapy, and those with higher stages also subsequently received radiotherapy plus concurrent weekly paclitaxel and carboplatin over 6 week s. The median age was 61 years, with 56 men and 46 women, and the predomina nt histologic type was adenocarcinoma. Twenty pneumonectomies, 80 lobectomi es, and 2 other procedures were performed. Ninety percent of the patients ( 92 of 102) received all 3 courses of adjuvant paclitaxel and carboplatin (8 4% received full doses). Seventy-three percent received full doses of radio therapy and concurrent weekly chemotherapy (49 of 67 patients), and 14 othe rs received greater than 75% of the radiotherapy and concurrent chemotherap y. Results. Toxicity of the chemotherapy was mild with only three hospitalizat ions for neutropenia and fever and no treatment-related deaths. Severe hype rsensitivity occurred in six patients (6%). Concurrent radiation therapy an d weekly chemotherapy also was well tolerated with the exception of Grade 3 -4 esophagitis observed in 27% (17 of 67 patients). Follow-up was short wit h a median of 10 months, and 65% of all patients remained progression free. Conclusions. Three courses of paclitaxel and carboplatin is tolerable, feas ible, and can be delivered in most patients in the adjuvant setting. Subseq uently, in higher stage patients, concurrent postoperative radiation therap y and weekly paclitaxel and carboplatin is well tolerated and delivered in most patients. Definitive prospective randomized Phase III adjuvant trials are warranted. Cancer 200 1;92: 2142-7. (C) 2001 American Cancer Society.