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OA 02 - Mesothelioma: Challenges For New Treatment (ID 653)
- Event: WCLC 2017
- Type: Oral
- Track: Mesothelioma
- Presentations: 1
OA 02.07 - Surgical Selection in Pleurectomy Decortication for Mesothelioma – an Overview from Screening and Selection from MARS 2 Pilot (ID 10185)
11:00 - 12:30 | Author(s): M. Trialists
Encouraging survival has been reported with pleurectomy decortication (PD) for malignant pleural mesothelioma (MPM) in several surgical case series. However, doubts remain over the degree of selection bias that constitutes the final composition of these series which therefore lead to questions surrounding the validity of the reported outcomes. We have reviewed our initial experience in the MARS 2 study to analyse this surgical selection process in more detail.
The MARS 2 pilot is randomised trial of RCT of 14 UK centres recruiting into a cisplatin/pemetrexed with or without the addition of PD for meseothelioma in those who remain suitable after an induction two cycle regime. We completed the pilot to analyse screening, eligibility, consent and randomisation data to estimate the eventual pool of patients considered suitable for surgery.
From 19 Jun 2015 to 5 Dec 2016, 331 patients were screened from the participating centres. In total, 254 patients were excluded, 176 for failed screening and 78 who declined participation. Of the 176, who failed screening the reasons were non resectable disease (74), poor performance status (24), not fit for surgery (4), not mesothelioma (6), death (5) and other (63). From the 331 screened participants, 77 were enrolled to and received the initial two cycles of chemotherapy and a further 21 withdrew. The reasons for withdrawal were declining randomisation (5), progressive disease (10) and other reasons (6), leaving 56 participants randomised into the trial.
Screening data of a prospective randomised trial (MARS 2) has provided a unique insight into the detailed selection process for PD for MPM. Exclusions occurred at multiple points in the pathway but these have identified potential points for intervention in patient education, staging and fitness assessment and the proportion of tumour progression which will inform the forthcoming phase III study. The clear extent of possible selection bias underscores the importance of evaluating the efficacy of surgery within the context of this randomised trial to be able derive robust estimates of treatment effect.
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