Author of

• 12573

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  P3.09 - Poster Session 3 - Combined Modality (ID 214)

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

  • 12591

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    P3.09-018 - IFCT-0803 Trial: a phase II study of cetuximab, pemetrexed, cisplatin and concurrent radiotherapy in patients with locally advanced, unresectable, stage III, non squamous, non-small cell lung cancer (NSCLC): preliminary safety analysis (ID 3281)

    09:30 - 09:30  |  Author(s): D. Lerouge
    • Abstract

    Background
    Cisplatin-based chemotherapy and concurrent radiotherapy are the standard treatments for locally advanced unresectable NSCLC. New therapeutic combinations using molecular targeted drugs are needed. IFCT-0803 Trial is a phase II study evaluating the benefit of adding cetuximab to a combination of concomitant radio-chemotherapy with cisplatin and pemetrexed in patients with stage III, non-squamous NSCLC. Data on safety and tolerance during the first 16 weeks of treatment, available after the inclusion of the first 62 eligible patients, are presented.

    Methods
    Based on a two-stage Simon approach, 106 patients will be included in IFCT-0803 trial. An interim analysis of the first 34 patients authorized the continuation of the study. Eligible patients receive conformal thoracic radiation with no elective nodal irradiation (66 Gy in 33 fractions, ICRU) along with cisplatin (75 mg/m[2]) and pemetrexed (500 mg/m[2]) on day 1 administered intravenously every 21 days for four cycles; weekly cetuximab (400 mg/m[2] for the first week, then 250 mg/m[2]) is added from the first week of therapy for a total of 12 doses. The primary objective is to assess the disease control rate at the 16[th] week, one month after treatment completion

    Results
    62 patients were included (37 male, 56 years mean age), PS 0 = 39 and PS 1 = 23, ever smoker = 57, stage IIIA = 31 and IIIB = 31, adenocarcinoma = 50. Compliance for the first 62 patients included was as follows: Day 1 chemotherapy was administered to 100% of patients on cycles 1 and 2, to 98.4% on cycle 3 and to 96.6% on cycle 4. Radiotherapy protocol was respected: median was 33 for number of fractions, 66 Gy for total dose, 46 days for duration of treatment, 39 patients had a maximal toxicity of grade 3 and 6 of grade 4. Table 1 lists the number of patients for the main categories of toxicity.

    n=62	grade 1/2	grade 3	grade 4
    anemia	32	4	0
    neutropenia	24	20	5
    thrombocytopenia	30	4	2*
    general toxicity	42	13	0
    skin toxicity	51	9	0
    digestive toxicity (nausea and vomiting)	42	6	0
    esophageal toxicity	43	10	0
    febrile neutropenia	-	5	0
    renal toxicity	4	3	0
    neurologic toxicity	11	0	0

    * :One patient died consecutively to a subdural hematoma caused by a fall, he had a grade 4 thrombocytopenia

    Conclusion
    IFCT-0803 trial is ongoing, the end of the inclusions is scheduled for October 2013. This combination therapy is feasible without any unexpected side effects.