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

  • 11674

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    P2.09-001 - Phase II study of concurrent chemo-radiotherapy (CRT) with weekly cisplatinum plus oral vinorelbine in fit elderly patients with nonresectable locally advanced non-small-cell lung cancer (NSCLC) assessed by Standardized Geriatric Assessment (RACCOSA, GFPC 08-06 study): interim analysis. (ID 233)

    09:30 - 09:30  |  Author(s): N. Pourel
    • Abstract

    Background
    Few studies are dedicated to elderly patients with unresectable stage IIIA/B. We used a Standardized Geriatric Assessment (SGA) to select fit elderly patients and assess if this population can benefit from standard of care, namely concurrent CRT.

    Methods
    The aim of this multicentric phase II opened-study was to assess CRT in patients older 70 years with locally advanced NSCLC, evaluated as “fit” according to SGA.CRT associated oral vinorelbine (30 mg/m²/week) and IV cisplatinum (30 mg/m²/week) during 6 weeks concurrently with radiotherapy (66 Gy, 33 fractions, 6,5 weeks). Main inclusion criterias were : PS ≤ 1, weight loss < 10%, creatinine clearance ³ 50 ml/mn abreviated, VEMS ³ 40%, PaO2 ³ 60 mm Hg, KCO ³ 60% and patient classified as fit according to SGA. The principal end-point was early treatment tolerance (number of patients with adverse event grade ³ 3 (except nausea and vomiting) or grade 4 for hematologic toxicity and asthenia. Secondary end-points were RECIST response 4 weeks after treatment, quality of life, tolerance, progression-free survival and overall survival. Using a Simon's optimal plan in 2 steps, the total number of patients to be included was 59 with an intermediate analysis after 19 patients. Toxicities and serious adverse events were monitored by an independent peer committee.

    Results
    Interim analysis was done after 23 inclusions in 19 evaluable patients: males 84% , mean age 74.6 (70 to 83) years, 3 patients didn’t end the treatment (1 disease progression, 1 cons-indication for radiotherapy, 1 patient choice). Four patients had adverse event ≥ 3 (except nausea and vomiting) or grade 4 hematologic toxicity and asthenia. Treatment efficacy was: 1 RC, 10 RP, 5 SD, 1 PD. Two patients were not evaluable (1 early death, 1 patient’s refusal to further treatment). The independent peer committee judged that toxicities were acceptable and consistent with what was expected. Study is ongoing with 44 enroled patients currently.

    Conclusion
    The interim analysis of a phase II study of CRT in fit elderly patients with no resecable locally advanced NSCLC assessed by SGA showed an acceptable toxicity. Results will be upgraded for the congress.