1585P - The impact of platinum-induced peripheral neuropathy (PN) in first-line treatment on PN and efficacy in second-line paclitaxel (PTX)-based chemotherapy for unresectable advanced gastric cancer (AGC): A prospective observational multicenter study - IVY study

Background

The IVY study (UMIN000033376) investigated the impact of first-line platinum-induced PN on the incidence of PN during second-line PTX-based chemotherapy and its efficacy in patients with unresectable AGC.

Methods

The study utilized the Common Terminology Criteria for Adverse Events (CTCAE), the Patient Neurotoxicity Questionnaire (PNQ), and the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) to assess PN. The primary endpoint was to determine the incidence of grade 3 or greater PN during second-line treatment in patients with and without PN at the start of treatment. The secondary objective was to examine the relationship between PN and the efficacy.

Results

Of 162 patients enrolled in this study, 156 received second-line PTX-based chemotherapy and were divided into two groups based on their PN status at the start of the treatment. The characteristics of 156 patients are as follows: the median age was 69 years, 72% were male, 90% were ECOG PS: 0 or 1, 81% used oxaliplatin in their first-line chemotherapy regimen. Of the 156 patients, 90 patients (58%) were in the group with PN (CTCAE grade: 1 to 3), and 66 were in the group without PN (grade: 0). The group with PN had a higher incidence of grade 3 or greater PN than the group without PN (16.7% vs. 4.6%, p=0.02). The progression-free survival and the overall response rate were not significantly different between the two groups (4.0 months in the group with PN vs. 3.5 months without PN, p=0.20; and 23% vs. 19%, p=0.69). However, the median overall survival was significantly better in the group with PN (10.3 months vs. 8.1 months, p=0.04). The quality-of-life scores, as assessed by PNQ and FACT/GOG-Ntx, were lower in the group with PN than the scores of the group without PN during two months of treatment.

Conclusions

Starting second-line PTX-based chemotherapy with existing PN increased the severity of PN during treatment. However, this adverse effect did not impact the effectiveness of second-line PTX-based chemotherapy for patients with unresectable AGC.

Clinical trial identification

UMIN000033376.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

T. Ando: Financial Interests, Institutional, Research Grant: Chugai Pharmaceutical Co., Ltd.; Financial Interests, Institutional, Invited Speaker: Otsuka Pharmaceutical Co., Ltd., Taiho, Daiichi Sankyo Company, Limited., Nippon Kayaku Co.,Ltd. All other authors have declared no conflicts of interest.