Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 1514
© 2005 American Society of Clinical Oncology

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Abstract

N997D: Pilot trial of CPT11 during RT followed by CPT11 and BCNU in newly diagnosed glioblastoma (GBM) patients: A North Central Cancer Group (NCCTG) study

Mayo Clinic, Jacksonville, FL; Mayo Clinic, Rochester, MN

1514

Background: Prior studies in gliomas have shown additive therapeutic effects of CPT11 and BCNU, and radiosensitizing effect of CPT11. We evaluated the toxicity of RT and concurrent CPT11, followed post-RT by BCNU plus CPT11 in patients (pts) with newly diagnosed GBM. Methods: All pts had GBM (WHO Grade 4) by central review. Those not receiving anticonvulsants (non-EIAC, Arm A) received RT with concomitant CPT11 (125mg/M2/wk X 4, cycle 1), followed post-RT by BCNU (100mg/M2 q 6 wk) + CPT11 (125 mg/M2/wk X 4, q 6 wks, cycles 2–5). Pts on EIAC (Arm B) received CPT11 (400mg/M2/wk X 4, cycle 1) during RT, then post-RT BCNU (100mg/M2 q 6 wk) + CPT11 (400mg/M2/wk q 6 wks, cycles 2–5). Dose de-escalations (but no escalations) were allowed. Toxicity was graded by CTCAE v 3.0. Results: All pts received treatment, and 3 cycles were administered in 7/16 non-EIAC and 6/12 EIAC pts. In Arm A (non-EIAC, 48 total cycles), the most frequent treatment-related grade 3 toxicities included neutropenia (25%), leukopenia (17%), and diarrhea (13%). Although cycle 1 during RT in Arm A was tolerated, unacceptable toxicity (hematologic) during cycles 2–5 required amending the protocol to reduce the CPT11 dose to 75 mg/M2/wk X 4 (cycles 2–5). In Arm A, there were a total of 40 grade 3, five grade 4, and one grade 5 (perforated ulcer) toxicities; 4 patients went off study due to toxicity. In Arm B (EIAC, 45 cycles), the most common treatment-related grade 3 toxicities included diarrhea (4%) and neutropenia (4%), with nine total grade 3 events, but no grade 4 or 5 events. Dose reductions were required in 10/12 EIAC pts, but no pt went off study due to toxicity. Three of 16 non-EIAC, and 4/12 EIAC pts completed study per protocol. Conclusions: Protocol-specific acceptable toxicity parameters were met for non-EIAC pts, using CPT11 (125mg/M2/wk X 4, cycle 1) during RT, followed post-RT by BCNU (100mg/M2 q 6 wk) + CPT11 (75 mg/M2/wk X 4, q 6 wks, cycles 2–5); and, for EIAC pts, using CPT11 400 mg/M2/wk X 4 during RT, followed post-RT by BCNU 100mg/M2 q 6 wk + CPT11 400 mg/M2/wk X 4 (cycles 2–5) q 6 wks. An expanded NCCTG Phase II efficacy study is in progress, utilizing these dose schedules.

No significant financial relationships to disclose.

Abstract presentation from the 2005 ASCO Annual Meeting