title: The benefit of adjuvant treatment for resected locally advanced non-small-cell lung cancer. The Lung Cancer Study Group.
abstract: The purpose of this trial was to investigate the impact of systemic combination chemotherapy on survival and recurrence patterns in incompletely resected non-small-cell lung cancer. Incomplete resection was defined as presence of residual tumor in the resection margin or by presence of metastasis in the highest paratracheal lymph node sampled during protocol-directed surgical staging of the mediastinum. One hundred seventy-two patients were randomized to receive either postoperative radiotherapy (RT) alone or postoperative RT plus chemotherapy with CAP (Cytoxan [cyclophosphamide; Bristol Myers, Evansville, IN], Adriamycin [doxorubicin; Adria Laboratories, Columbus, OH], and Platinol [cisplatin; Bristol Myers]) for 6 months. One hundred sixty-four patients were eligible for analysis at a mean time since randomization of 3.7 years. The chemotherapy arm showed significantly longer recurrence-free survival (two-sided Mantel-Haenszel log rank test, P = .004). This difference holds true for nonsquamous patients (P = .01), and approaches significance for squamous patients as well (P = .08). There was a 14% difference in survival rate favoring the chemotherapy arm 1 year after randomization. Analysis of sites of recurrence showed a significant decrease in distant metastases in the chemotherapy arm. Median survival for the entire group was approximately 17 months, and 35% are alive 2 years after resection. Toxicity of treatment consisted of esophagitis (mild-moderate by Eastern Cooperative Oncology Group [ECOG] criteria) and predictable hematologic, gastrointestinal (GI), and skin toxicity expected from CAP.
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002283:Carcinoma, Bronchogenic / Q000401:mortality / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000628:therapy*; D011182:Postoperative Care; D011879:Radiotherapy Dosage; D011897:Random Allocation; D013997:Time Factors
chemical_list: D004317:Doxorubicin; D003520:Cyclophosphamide; D002945:Cisplatin