Abstract 246P
Background
The efficacy and safety of nanosomal paclitaxel lipid suspension [NPLS; 175 and 80 mg/m2 every 3-weekly (Q3W) and weekly (QW)] versus conventional paclitaxel (175 mg/m2 Q3W) in metastatic breast cancer (MBC) patients has been established in a previous phase II/III study. The current extension study presents the updated data of 174 patients (main study: N=120; extended study: N=54).
Methods
In this prospective, phase II/III, open-label study, female MBC patients (N=120) aged 18-65 years who had failed previous chemotherapy were randomized (2:2:1) to NPLS 175 mg/m2 Q3W (n=48, 6 cycles, arm A), NPLS 80 mg/m2 QW (n=45, 18 cycles, arm B), or conventional paclitaxel 175 mg/m2 Q3W (n=27, 6 cycles, arm C). In the extension study, an additional 54 patients were randomized (2:1) to arm A (n=37) or arm C (n=17). The efficacy outcomes were overall response rate (ORR; complete response [CR]+partial response [PR]) and disease control rates (DCR; CR+PR+stable disease [SD]).
Results
All 174 patients qualified for safety analysis and 168 were evaluable for efficacy. A higher ORR was reported for arm A (30.86%) and arm B (44.44%) versus arm C (23.81%) respectively. Similarly, a high DCR rate was reported for arm A (80.85%) and arm B (84.44%) versus arm C (76.19%). Peripheral sensory neuropathy, diarrhea, vomiting, and anorexia were less frequent with NPLS versus conventional paclitaxel. NPLS was well-tolerated without any new safety concerns. Table: 246P
Study outcomes
| Parameter | NPLS 175 mg/m2 (N=81), Arm A, n (%) | NPLS 80 mg/m2 (N=45), Arm B, n (%) | Conventional paclitaxel 175 mg/m2 (N=42), Arm C, n (%) | P-Value Arm A vs. Arm C | P-Value Arm B vs. Arm C |
| CR | 3 (3.70) | 0 (0) | 0 (0) | 0.5503 | - |
| PR | 22 (27.16) | 20 (44.44) | 10 (23.81) | 0.8290 | 0.0701 |
| SD | 40 (49.38) | 18 (40.00) | 22 (52.38) | 0.8497 | 0.2860 |
| ORR (CR+PR) | 25 (30.86) | 20 (44.44) | 10 (23.81) | 0.5281 | 0.0701 |
| DCR (CR+PR+SD) | 65 (80.85) | 38 (84.44) | 32 (76.19) | 0.6449 | 0.4203 |
| AEs of interest | |||||
| Peripheral sensory neuropathy | 4 (4.71) | 4 (8.89) | 7 (15.91) | ||
| Diarrhea | 5 (5.88) | 4 (8.89) | 5 (11.36) | ||
| Vomiting | 6 (7.06) | 5 (11.11) | 4 (9.09) | ||
| Anorexia | 5 (5.88) | 0 (0) | 5 (11.36) |
Conclusions
NPLS demonstrated a relatively higher tumor response rate versus conventional paclitaxel in MBC patients. Overall, NPLS was well-tolerated without any significant safety concerns.
Clinical trial identification
CTRI/2010/091/001344. Last modified on 24/11/2018. Available from http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=2135&EncHid=&modid=&compid=%27,%272135det%27.
Editorial acknowledgement
Mr. Shreekant Sharma (CMPPTM ISMPP, Intas Pharmaceuticals Limited, India) provided medical writing assistance for the study.
Legal entity responsible for the study
Lambda Therapeutic Research Limited, Ahmedabad, India.
Funding
Intas Pharmaceuticals Limited.
Disclosure
S. Chiradoni Thungappa, R. Taran, J.K. Singh, S.P. Shrivastav, N.K. Vithalani, K.K. Mukherjee, R. Nagarkar, T.M. Maksud, A. Mehta, K. Srinivasan, M. Vikranth, S.R. Sonawane: Financial Interests, Institutional, Principal Investigator: Intas Pharmaceuticals Limited. A. Ahmad, S. Sheikh, S.M. Ali, M. Paithankar, A. Rajani, D. Bunger, M.A. Khan, I. Ahmad: Financial Interests, Institutional, Full or part-time Employment: Jina Pharmaceuticals; Financial Interests, Institutional, Sponsor/Funding: Jina Pharmaceuticals.