CTNI-34. TOXICITY PROFILE AND COMPLIANCE OF PATIENTS WITH HIGH RISK GRADE 2 OR GRADE 3 GLIOMAS RECEIVING ADJUVANT PCV VERSUS ADJUVANT TEMOZOLOMIDE

Abstract

INTRODUCTION: The NCCN recommends either PCV (Procarbazine, CCNU and vincristine) or Temozolomide (TMZ) as adjuvant therapy in high‐risk grade 2 & grade 3 gliomas. In this ongoing study we are comparing PCV with TMZ as adjuvant therapy in this setting. METHODS: This is a randomised phase 3 study that includes patients with high risk (as per RTOG) grade 2 gliomas and grade 3 gliomas after surgery. Patient are randomly assigned in 1: 2 to receive either adjuvant PCV or TMZ after adjuvant RT. The primary end‐point is progression‐free survival & key secondary end points are overall survival, toxicity and quality of life. The current analysis focuses on the compliance and adverse events seen in patients enrolled till 30th April 2020. RESULTS: 46 patients were enrolled, with 30 patients in TMZ arm. The median age of patients was 37 years (range 23‐64). The ECOG PS was 1 in 45 (97.8%) patients and 2 in 1(2.2%) patient at enrolment. The number of patients who have completed all planned cycles of chemotherapy in the PCV arm is 62.5% (10, n=16) as compared to 90% (27, n=30) in the TMZ arm (P=0.047). The incidence of grade 3 or higher adverse events is 68.8% (n=11) in the PCV arm and 16.7% (n=5) in the TMZ arm (P=0.001). The most common grade 3 or higher toxicities noted are lymphopenia in 50% (n=8), neutropenia in 37.5% (n=6), and thrombocytopenia in 25% (n=4) in the PCV arm; while the corresponding numbers in the TMZ arm are 13.3% (n=4), 3.3% (n=1) and 10% (n=3) respectively. CONCLUSION: In the current study the chemotherapy completion rates are higher with TMZ and it is associated with lower grade 3‐4 events, whether this will lead to an improvement in outcomes remains to be seen.