1239P - Feasibility of home delivery (HD) of maintenance pemetrexed (PEM) therapy for advanced nonsquamous non small cell lung cancer (adv nsqNSCLC)

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Bioethics, Legal, and Economic Issues
Non-Small-Cell Lung Cancer, Metastatic
Presenter Rohit Lal
Citation Annals of Oncology (2014) 25 (suppl_4): iv426-iv470. 10.1093/annonc/mdu349
Authors R. Lal1, Y. Summers2, R. Shah3, B. Crosse4, J. Thompson5, M.C. Nicolson6, V. Potter7, A. Vikström8, C.M. Visseren-Grul9, M. Lorenzo10, Y. D'Yachkova11, N. Bourayou12, G. Hillerdal13
  • 1Guys Hospital - Department Of Oncology - Management Offices - Bermondsey Wing 4th Floor, Guy's and St. Thomas' Hospital NHS Trust, SE1 9RT/SE1 7EH - London/GB
  • 2Medical Oncology, The Christie NHS Foundation Trust & University Hospital South Manchester NHS Foundation Trust, M23 9LT - Manchester/GB
  • 3Kent Oncology Centre, Maidstone and Tunbridge Wells NHS Trust, ME16 9QQ - Maidstone/GB
  • 4Oncology/lung And Gynecological Cancers, Calderdale & Huddersfield NHS Trust, HD3 3EA - Huddersfield/GB
  • 5Oncology/lung Cancer, Birmingham Heartlands Hopsital, B9 5SS - Birmingham/GB
  • 6Medical Oncology, Aberdeen Royal Infirmary, GB-AB25 2ZN - Aberdeen/GB
  • 7Department Of Oncology, Nottingham University Hospitals NHS Trust, NG5 1PB - Nottingham/GB
  • 8Pulmonary Clinic, Universitetssjukhuset, 581 85 - Linköping/SE
  • 9Medical Oncology, Eli Lilly and Company, 3991 RA - Houten/NL
  • 10Medical Oncology, Eli Lilly and Company, GU20 6PH - Windlesham, Surrey/GB
  • 11Medical Oncology, Eli Lilly GmbH, A-1030 - Vienna/AT
  • 12Medical Oncology, Eli Lilly and Company, 92521 - Neuilly-sur-Seine Cedex/FR
  • 13Department Of Medicine, Karolinska Universitetsjukhuset, SE-171 76 - Solna/SE

Abstract

Aim

Some patients with adv nsqNSCLC may not need hospital-based chemotherapy. This study evaluated the feasibility and adherence to HD of maintenance PEM therapy in these patients. PEM is suitable for HD due to its favorable safety profile and ease of use (10-minute i.v. infusion).

Methods

Exploratory, prospective, single-arm, Phase 2 study in adv nsqNSCLC patients, ECOG performance status 0 or 1 without progression after 4 induction cycles of platinum doublet. The first cycle of PEM (500mg/m2) was hospital administered, further cycles as HD until progressive disease or discontinuation. Feasibility was assessed by the adherence rate to HD (probability of reversion to hospital administration or discontinuation due to HD) as primary endpoint, and by health related quality of life (HRQoL) (EQ-5D, lung cancer symptom scale [LCSS]), satisfaction with HD, Overall Survival (OS), and safety.

Results

52 patients (UK/Sweden) had a median of 4 (range 1-19) maintenance PEM cycles. Adherence rate up to Cycle 6 was 98% (95% CI: 86.4%, 99.7%). All but 2 patients remained on HD. 1 patient discontinued after Cycle 1 (before first HD, [safety concerns]) and 1 patient after Cycle 6 (investigator decision [non-compliance with oral dexamethasone]). 82% (31/38) patients preferred home treatment and in 90% (28/31) of cases, physicians were satisfied with distant patient management. During HD Cycles 2-4 mean change from baseline ranged from 3-8 for EQ-5D VAS and from –5 to –8 for LCSS average symptom burden index. The 6-month OS rate was 73% (95% CI: 58%, 83%). 1 patient had an HD related AE (device related infection Grade [G] 2) and 1 patient died (possibly drug related atypical pneumonia).

National Cancer Institute Common Terminology Criteria for AEs (V4) G 3/4 toxicities

AEs n (%)
Fatigue 6 (12)
Anemia 4 (8)
Dyspnea 3 (6)
Thrombocytopenia 2 (4)
Lower respiratory infection 2 (4)
Neutropenia 1 (2)
Nausea 1 (2)
Pulmonary fibrosis 1 (2)
Sepsis 1 (2)

Conclusions

HD of maintenance PEM therapy in adv nsqNSCLC was feasible, safe, and preferred by patients, while maintaining HRQoL. Physicians were satisfied with distant patient management. Community-based clinical research requires specific consideration and resource allocation.

Disclosure

M.C. Nicolson: The author has a personal specific interest in terms of advisory board work and also paid lectures for Lilly; also non-personal specific in terms of research support and meeting attendance support; C.M. Visseren-Grul: Lilly Employee The author declares no conflict of interest; M. Lorenzo: Lilly Employee The author declares no conflict of interest; Y. D'Yachkova: Lilly Employee The author declares no conflict of interest; N. Bourayou: Lilly Employee The author declares no conflict of interest. All other authors have declared no conflicts of interest.