Phase II trial of concurrent paclitaxel, carboplatin, and external-beam radiation followed by surgical resection in locally advanced non-small-cell lung cancer, protocol 99-444.
OBJECTIVE
We conducted a phase II study to evaluate the utility and outcomes of concurrent weekly low-dose chemotherapy with concurrent radiation in an effort to "downstage" patients with locally advanced non-small-cell lung cancer (NSCLC).


METHODS
Eighteen patients with pathologically confirmed stage IIIA (T1-3 N2 or T3 N1) and 3 patients with stage IIB (T3 N0) NSCLC were enrolled. Seventeen of 18 patients with stage IIIA cancer had N2 disease. A chemotherapy/radiation schedule consisted of paclitaxel 50 mg/m(2 )and carboplatin administered at an area under the curve of 2 weekly for 5 weeks along with chest irradiation of 45 Gy. Patients with regressed or stable disease upon restaging were considered surgical candidates. Patients deemed inoperable were given additional radiation therapy.


RESULTS
Twenty-one patients were enrolled from April 2000 to March 2004. Data from 21 patients were available for evaluation at the time of analysis. Grade 3/4 constitutional and pulmonary toxicity was <or= 10%. Grade 3/4 lymphopenia was noted in 9.5% of patients. One treatment-related death from postoperative acute respiratory distress syndrome occurred. Seventeen of 21 patients completed neoadjuvant therapy and 15 patients underwent resection. Four of 15 patients had a complete histopathologic response at the time of resection. Follow-up data were available on 20 patients. Overall, the median progression-free survival was 14.1 months. The median overall survival was 26.1 months. Six of 20 patients remain relapse free (range, 19.3-70.8 months).


CONCLUSIONS
Neoadjuvant low-dose weekly chemotherapy given concurrently with conventional chest irradiation might improve outcomes in patients with stage IIB and IIIA NSCLC with acceptable toxicity.
Fischer
Sean A
SA
Department of Medical Oncology, Washington Cancer Institute, Washington, DC 20010, USA.
Soberman
Mark
M
Randolph
Pamela
P
Crawford
Kevin
K
Perry
David J
DJ
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage
D016190:Carboplatin; D017239:Paclitaxel