Author of

• 11673

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  P2.09 - Poster Session 2 - Combined Modality (ID 213)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Combined Modality
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 11677

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    P2.09-004 - Phase II study of sequential versus concurrent chemotherapy and radiotherapy in poor risk patients with inoperable stage III non-small cell lung cancer (NSCLC): final results of the Spanish Lung Cancer Group 00-05 study (ID 1102)

    09:30 - 09:30  |  Author(s): J. Valencia
    • Abstract

    Background
    Inoperable stage III NSCLC is increasingly diagnosed in poor-risk patients for whom there is not yet a standard treatment. We conducted a randomized two-stage phase II study to assess whether sequential or concurrent chemoradiation was feasible, tolerable and showed efficacy.

    Methods
    Patients with inoperable stage IIIA and B NSCLC and at least one of the following conditions: age ≤ 75 years, ECOG PS=2, weight loss > 5%, creatinine clearance < 60 ml/min, a comorbid condition precluding the patient from being treated in a protocol for fit patients,were randomized to receive either carboplatin AUC 2.5 and vinorelbine 15 mg /m[2] both on days 1,8,22, and 29, and thoracic radiotherapy (TRT) total dose 60 Gy starting day 1 (CT arm) or, carboplatin AUC 5, days 1 and 22 and vinorelbine 25 mg/m[2] days 1, 8, 22, and 29, followed by TRT 60 Gy starting day 43 to 50 (ST arm). The primary end-point was response rate.

    Results
    From June 2001 to June 2006, 70 patients from 8 centers were included : 47 in CT arm and 23 in ST arm. Forty-eight of these patients were randomized during the first stage of the trial. By September 2004, due to a decrease in treatment compliance and an increase in early deaths in the ST arm, accrual was continued in the second stage of the trial only in the CT arm. Patient characteristics: median age 74 (49-84), Male 96%, Stage IIIB 65%; ECOG =2, 28%; Weight loss >5%, 29%; Creatinine clearence <60, 26%; Comorbidity, 70%. More than one poor risk inclusion criteria: 59 %. Fifty-eight patients completed treatment 93 % in CT arm, and 73% in ST arm. There were 2 CR and 25 PR (RR 60%) in CT arm, and 10 PR (RR 45.5%) in ST arm. Grade 3- 4 hematological toxicity was absent in CT arm and was 14% (neutropenia) in ST arm. Grade 3 and 4 non-hematological toxicities experienced by more than 5% of patients were asthenia (7%) and dyspnea (9%) in CT arm and anorexia (9%), asthenia(14%), and dyspnea (14%) in ST arm. Only one patient developed grade 3 esophagitis (CT arm) There were five deaths during treatment: two in CT arm and three in ST arm. Median PFS and overall survival rate were 6.7 (95% CI:4.9-8.5) and 16.8 months (95% CI 9.5-24), and 7.9 (95% CI:3.9-16.2) and 5.6 months (95% CI:2.7-8.9 ), for the CT arm and ST arm, respectively.

    Conclusion
    In poor-risk patients with inoperable stage III NSCLC, concurrent chemoradiotherapy outperformed sequential chemotherapy and radiotherapy, and was feasible, very well tolerated, and provided efficacy. The survival outcome with concurrent chemoradiotherapy was notably longer than anticipated.