B110
Pemetrexed alone or in combination with cisplatin or carboplatin in chemonave/pretreated inoperable patients with malignant pleural mesothelioma (MPM): UK results of an international expanded access programme (IEAP)
Mary O'Brien1, Michael Snee2, Clive Mulatero2, Mayukh Das3, Bhikhubhai Kalidas3, Alexandra Thareau Vaury4
1Royal Marsden Hospital, Sutton, UK, 2St James Hospital, Leeds, UK, 3Eli Lilly & Co Oncology, Basingtoke, UK, 4Eli Lilly France, Suresnes, France
Background
We report UK subset data from MPM patients in an IEAP run across 13 countries. Primary aim was to allow patient access and gain further clinical experience during regulatory review. Secondary objectives were to determine best overall tumour response, time to progressive disease (TTPD) and perform safety analysis.
Method
Eligible adult patients (N=544, 441 chemonave,103 pretreated), who satisfied predetermined criteria, including KPS ≥70%, were chosen by investigator to receive 500 mg/m pemetrexed (P) alone, or in combination with either 75 mg/m cisplatin (C), or AUC 5 carboplatin (Cb) in 21 day cycle until progressive disease, unacceptable toxicity, or investigator/patient decision. Dexamethasone prophylaxis and vitamin supplementation were also included. Amongst study participants, 160 in P/C arm, 204 in P/Cb arm and 48 in P arm were evaluable for efficacy.
Results
Clinical end points for groups P/C (n=203), P/Cb (n=254) and P (n=70).
RR % (95% CI): PC 20.0 (14.1, 27.0); PCb 18.1 (13.1, 24.1); P 6.3 (1.3, 17.2)
SD % (95% CI): PC 53.8 (45.7, 61.7); PCb 57.4 (50.3, 64.2); P 45.8 (31.4, 60.8)
CBR%* (95% CI): PC 73.8 (66.2, 80.4); PCb 75.5 (69.0, 81.2); P 52.1 (37.2, 66.7)
TTPD med months (95% CI): PC 5.5 (4.4, 21.2); PCb 6.2 (5.5, 6.9); P 3.7 (3.5, 4.5)
Neutropaenia Gr 3/4 (% pts): PC 13.8; PCb 34.9; P 12.1
Thrombocytopaenia Grade 3/4 (% pts): PC 3.6; PCb 15.4; P 1.5
Anaemia Gr 3/4 (% pts): PC 4.6; PCb 7.5; P 1.5
Med Cycles Chemo (range): PC 4.0 (1.0-8.0); PCb 5.0 (1.0-10.0); P 3.0 (1.0-7.0)
CBR%* = Clinical Benefit Rate
Conclusion
Findings in 544 UK patients confirm results published in full study article
for 13 countries. Pemetrexed/cisplatin and pemetrexed/carboplatin combinations
in MPM patients demonstrate clinically similar TTPD. Pemetrexed monotherapy was
observed to be relatively less toxic than pemetrexed/cisplatin, which was less
toxic than pemetrexed/carboplatin.
