Irinotecan/temozolomide (I/T) in conjunction with 1 of 2 other drug regimens shows promise in patients with relapsed or refractory neuroblastoma, according to a study presented at the American Society of Clinical Oncology (ASCO) 2016 meeting.1
Researchers enrolled 35 eligible patients, with a median age of 5.7 years, to this phase 2, randomized, 2-armed Children’s Oncology Group study. Of the 35, 18 were assigned randomly to Arm A, and received I/T in conjunction with temsirolimus (TEM); the other 17 were assigned randomly to Arm B, and received I/T in conjunction with dinutuximab plus granulocyte colony stimulating factor (DIN/GMCSF).
One patient in Arm A achieved a partial response; 53% in Arm B achieved the objective response: 4 partial, 5 complete. Five responses in Arm B were observed out of the 10 patients with relapsed/progressive neuroblastoma, and 4 responses in Arm B were observed out of the 7 patients with refractory disease.
The researchers concluded that both regimens showed significant antitumor activity in observed patients, though only the Arm B drug combination met the criteria for further study. A single unexpected adverse event was 1 case of Grade 4 hypoxia in Arm B.
- Mody R, Naranjo A, Ryn CV, Yu AL, London WB, Shulkin BL, et al. Phase II randomized trial of irinotecan/temozolomide (I/T) with temsirolimus (TEM) or dinutuximab plus granulocyte colony stimulating factor (DIN/GMCSF) in children with refractory or relapsed neuroblastoma: A report from the Children’s Oncology Group (COG). J Clin Oncol. 2016; 34 (suppl; abstr 10502).