Predictors of Long-Term Survival in Patients with Lung Cancer Included in the Randomized Spanish Lung Cancer Group 0008 Phase II Trial Using Concomitant Chemoradiation with Docetaxel and Carboplatin plus Induction or Consolidation Chemotherapy

Docetaxel and Carboplatin Plus Induction or Consolidation Chemotherapy

Pilar Garrido; Rafael Rosell; Bartomeu Massutí; Felipe Cardenal; Vicente Alberola; Manuel Dómine; Inmaculada Maeztu; Alfredo Ramos; Antonio Arellano

Disclosures

Clin Lung Cancer. 2009;10(3):180-186. 

In This Article

Patients and Methods

Eligibility Criteria

Only patients enrolled in the randomized phase II SLCG 0008 study were evaluated. All patients had histologic or cytologic evidence of unresectable stage IIIA or IIIB NSCLC without pleural effusion. Only patients with a Karnofsky index (KI) ≥ 70 were eligible. Other inclusion criteria required were a weight loss ≤ 5% in the 3 months preceding the study, a preregistration forced expiratory volume in 1 second (FEV1) of > 30% or 1 L, a diffusing capacity of the lung for carbon monoxide > 30%, and a 3-dimensional planning computed tomography scan in the 21 days before study entry that excluded a planning target volume > 2000 cm3 and/or a V20 > 35%. The study was reviewed and approved by the institutional review boards at all participating institutions. All patients provided signed informed consent. Toxicity and long-term results of the trial have previously been reported.[7,8]

Pretreatment Characteristics and Study Design

Initially, all patients were randomized to sequential CT/TRT, concomitant CT/TRT followed by consolidation CT, or induction CT followed by concomitant CT/TRT. However, based on the results of the Radiation Therapy Oncology Group (RTOG) 9410 trial, the sequential arm was closed when 19 patients had been enrolled (Figure 1). In the 2 concomitant arms, all patients received 2 cycles of docetaxel 40 mg/m2 on days 1 and 8 plus gemcitabine 1200 mg/m2 on days 1 and 8, as either induction or consolidation therapy. Concomitant treatment consisted of docetaxel 20 mg/m2 and carboplatin area under the curve of 2 weekly plus 60 Gy TRT.

Figure 1.

Spanish Lung Cancer Group 0008 Randomized Phase II Trial: Design

From May 2001 to June 2006, 158 patients were included (19 in the sequential arm, 70 in the consolidation arm, 69 in the induction arm). Because of the early closing of the sequential arm, only data on patients enrolled in the concomitant arms were included in this retrospective analysis. The prestudy evaluation included a complete medical history and physical evaluation, laboratory analysis, pulmonary function test, electrocardiogram, computed tomography scans of the chest and abdomen 4 weeks before study entry, and a planning computed tomography scan. A bone scan and brain magnetic resonance imaging were performed only if clinically indicated. Positron emission tomography was not available at that time. The baseline characteristics of the patients are shown in Table 1 .

Statistical Analyses

Baseline characteristics were compared between treatment groups using t test for continuous variables and Fisher exact test for discrete variables. Median survival times were computed using the life test procedure and compared by the log-rank test. A univariate analysis of prognostic factors was performed on all patients, using the log-rank test. A Cox proportional hazards regression model was performed including the following variables: age (< 70 years vs. > 70 years), sex, Eastern Cooperative Oncology Group PS (0 vs. 1), histology (squamous vs. non-squamous cell carcinoma), FEV1 (> 2 L vs. 1-2 L), disease stage (IIIA vs. IIIB), nodal status (N0 vs. N1-2 vs. N3), hemoglobin (Hb) level (≥ 12 g/dL vs. < 12 g/dL), completion of TRT (yes vs. no), completion of induction or consolidation plus concomitant treatment (yes vs. no), and TRT delay (≥ 7 days vs. < 7 days).

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