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Poster Discussion - Non-metastatic NSCLC and other thoracic malignancies

3307 - Switch Maintenance Gemcitabine After First Line Chemotherapy In Patients With Malignant Mesothelioma; A Multicenter Open Label Phase II Trial (NVALT19)

Date

29 Sep 2019

Session

Poster Discussion - Non-metastatic NSCLC and other thoracic malignancies

Presenters

Sjaak Burgers

Citation

Annals of Oncology (2019) 30 (suppl_5): v851-v934. 10.1093/annonc/mdz394

Authors

S.A. Burgers1, C. de Gooijer1, R. Cornelissen2, J.G. Aerts2, B. Biesma3, R.V. Heemst4, M. Youssef-El Soud5, H.J.M. Groen6, A.J. Staal-van den Brekel7, G. Bootsma8, J.H.E.M. Schijen9, P. Baas1, E. Giovannetti10, J.F. de Vries11, F.A. Hogenboom11, D.C.M. de Wit11, M.C.W. Mahn- Schaefers1, F. Lalezari12, V. van de Noort11, J. Stigt13

Author affiliations

  • 1 Thoracic Oncology, Netherlands Cancer Institute/Antoni van Leeuwenhoek hospital (NKI-AVL), 1066 CX - Amsterdam/NL
  • 2 Pulmonary Diseases, Erasmus University Medical Center, 3015 CE - Rotterdam/NL
  • 3 Pulmonary Diseases, Jeroen Bosch Hospital, 5223GZ - 's-Hertogenbosch/NL
  • 4 Pulmonary Diseases, Deventer Hospital, 7116 SE - Deventer/NL
  • 5 Pulmonary Diseases, Maxima Medisch Centrum, 5631 BM - Eindhoven/NL
  • 6 Pulmonary Diseases, University Hospital Groningen (UMCG), 9700 RB - Groningen/NL
  • 7 Pulmonary Diseases, ZGT Hengelo, 7555DL - Henglo/NL
  • 8 Pulmonary Diseases, Zuyderland Medical Center, 6419 PC - Heerlen/NL
  • 9 Pulmonary Diseases, Elisabeth-Tweesteden Hospital, 5022 GC - Tilburg/NL
  • 10 Medical Oncology, Vrije University Medical Centre (VUMC), 1081 HV - Amsterdam/NL
  • 11 Biometrics, NVALT Study Centre, Amsterdam/NL, 1066 CX - Amsterdam/NL
  • 12 Radiology, Netherlands Cancer Institute/Antoni van Leeuwenhoek hospital (NKI-AVL), 1066 CX - Amsterdam/NL
  • 13 Pulmonary Diseases, Isala, 8025 AB - Zwolle/NL

Resources

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Abstract 3307

Background

All malignant mesothelioma (MM) patients progress after first-line therapy. We examined whether switch maintenance gemcitabine in patients, who did not show progression after first-line platinum-pemetrexed, could prolong time to disease progression.

Methods

NVALT19 was an open label, randomized phase II trial, conducted in The Netherlands. Main eligibility criteria were pathologically proven MM, ECOG-PS 0-2 and completion of 4-6 cycles of first-line platinum-pemetrexed without progression. Patients were randomized 1:1 between gemcitabine (1250 mg/m2 day 1 and 8 of 3 weekly schedule) or best supportive care (BSC). Gemcitabine was given until disease progression, severe toxicity or patient request for discontinuation. Primary endpoint was progression free survival (PFS) determined by local physician according to modified RECIST (mRECIST) or death in the intention-to-treat population. It was computed that 118 events would yield 90% power to detect an increase in PFS from median 3.5 months to median 6 months at 90% confidence level.

Results

Between March 2014 and February 2019, 130 patients were randomized, 65 in each arm. PFS was significantly longer with gemcitabine (median 6.2 months [range 4.6-8.7m]) than in the BSC arm (3.2 [2.8-4.2m]; hazard ratio 0.42; 95% confidence interval [CI], 0.28-0.63; p < 0.0001). The PFS probability at 12 months was 25% for Maintenance Gemcitabine (95% CI: 16.3 - 38.5%) and 3.3% for BSC (95% CI: 0.8 - 13%). Central revision of PFS, by a blinded radiologist, also showed significant benefit for gemcitabine (median 5.3 months [4.2-7.1m]) above BSC (2.8 [2.5-3.3m]; hazard ratio 0.42; 95% CI 0.28 to 0.62; p < 0.0001). Grade 3-4 adverse events (AE) occurred more in the gemcitabine arm (57% of patients) vs 13% in the BSC-arm. Neutropenia (22%), nausea (6%) and lung infection (5%) were most common treatment related grade III AE’s. Three patients (5%) experienced grade IV neutropenia. One patient died in the gemcitabine arm due to treatment related sepsis. Data on dose intensity will follow at ESMO 2019.

Conclusions

Switch maintenance gemcitabine after first-line chemotherapy significantly improves the PFS in malignant mesothelioma, with a manageable toxicity profile.

Clinical trial identification

NTR4132.

Editorial acknowledgement

Legal entity responsible for the study

Stichting NVALT studies.

Funding

Dutch Cancer Society and Stichting NVALT studies.

Disclosure

All authors have declared no conflicts of interest.

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