Author of

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  P2.06 - Mesothelioma (Not CME Accredited Session) (ID 955)

  • Event: WCLC 2018
  • Type: Poster Viewing in the Exhibit Hall
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall

  • 27046

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    P2.06-36 - EORTC 1205: Randomized Phase II Study of Pleurectomy/Decortication Preceded or Followed by Chemotherapy in Early Stage MPM (ID 11962)

    16:45 - 18:00  |  Author(s): Eleonora De Maio
    • Abstract
    • Slides

    Background
    

    Case series show a prolonged survival in resectable malignant pleural mesothelioma (MPM) with a combined modality approach of surgery and chemotherapy.

    Extrapleural pneumonectomy is the most commonly used surgical procedure in MPM, but is associated with a significant morbidity; the MARS trial (Treasure, Lancet Oncol 2011) suggests no outcome benefit and a possible harm to the patient.

    Retrospective studies suggest a better outcome with lung sparing resection (extended pleurectomy/decortication, e-P/D), but the procedure lacks uniformity and standardization. The optimal sequence of surgery and chemotherapy, the latter given either adjuvant or neo-adjuvant has not yet been determined.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    EORTC 1205 is a phase II, randomized (1:1) multi-centre trial comparing both approaches. Primary end-point is the successful completion of the multimodality treatment within 20 weeks. Secondary end-points are PFS, OS, treatment-failure-free survival (TFFS), toxicity/safety, operative mortality/morbidity and surgical quality and uniformity indicators.

    Patients with pathologically proven malignant pleural mesothelioma of all histological subtypes, early stage (cT1-3 N0-2 M0 according to TNM 7), WHO-PS 0-1 and fit for chemotherapy and surgery are eligible.

    No previous treatment, including prophylactic track irradiation, is allowed, except for diagnostic thoracoscopy with talc pleurodesis, which must be performed before randomization.

    Patients are randomized between arm A - immediate surgery (extended pleurectomy/decortication), followed by 3 cycles of cisplatin 75 mg/m² plus pemetrexed 500 mg/m² on day 1 q3w, or arm B - deferred surgery, preceded by 3 cycles of chemotherapy.

    4c3880bb027f159e801041b1021e88e8 Result
    

    Currently 4 of 6 planned sites have opened and 10 patients have been randomized in 2 centres.

    	Arm A (n=5)	Arm B (n=5)
    Male/female	4/1	4/1
    Median age	59.4 years [54.6-76.9]	67.1 years [58.8-69.1]
    Median PS	1 [0-1]	0 [0-1]
    Stage I/II/III	3/2/0	3/0/2

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    EORTC 1205 addresses the issue of optimally sequencing chemotherapy and e-P/D and will rigorously record the quality of the latter in a multicentre setting. Accrual is ongoing according to expectation. Updated interim results will be presented at the WCLC meeting.

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