578P - A retrospective observational study of efficacy and safety of Genexol-PM, a novel Cremophor-free, polymeric micelle formulation of paclitaxel, in p...

Date 18 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Anti-Cancer Agents & Biologic Therapy
Presenter Amit Bhatt
Citation Annals of Oncology (2016) 27 (suppl_9): ix184-ix189. 10.1093/annonc/mdw603
Authors A.D. Bhatt, A.A. Ranade
  • Medical Oncology, AVINASH CANCER CLINIC, 411038 - Pune/IN

Abstract

Background

Genexol-PM is a novel Cremophor EL (CrEL)-free polymeric micelle formulation of paclitaxel. This retrospective observational study was designed to evaluate the efficacy and safety of the combination of Genexol-PM in patient with solid tumour malignancies

Methods

Patients with solid tumour malignancies received Genexol-PM 125mg/m2 as a single agent weekly therapy or in combination with platinum doublet, 230 mg/m(2) on day 1 of a 3-week cycle. Data was analyzed retrospective at completion of scheduled therapy through chart review.

Results

Forty eight patients were enrolled in this study. Cancer of the breast (21), gynaecological cancer(12), Lung(2), Upper GI(6) were among the included solid tumours. 77.08% were having advanced cancers. 66.67% had received previous chemotherapy regimes. 72.92% received weekly therapy of Genexol-PM. Response rate at Interval assessment was 77.8%. Response rate in advanced cancers at the end of schedule therapy was 60.4%. The major non-hematologic toxic effects included grade 3 peripheral sensory neuropathy (14.6%). Adjustment in doses were required in 41.6% patients. One patient (2.08%) experienced grade 3/4 hypersensitivity reactions. The major haematological toxic effects were grade 3/4 neutropenia requiring hospital admission were 27.08%.

Conclusions

Genexol-PM, either as a single agent or in combination chemotherapy showed significant antitumor activity. The use of CrEL-free, polymeric micelle formulation of paclitaxel allowed administration of higher doses of paclitaxel compared with the CrEL-based formulation with comparable toxicity profiles

Clinical trial indentification

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Legal entity responsible for the study

Avinash Cancer Clinic

Funding

N/A

Disclosure

All authors have declared no conflicts of interest.