Vincristine, irinotecan, temozolamide for pediatric solid cancers – pro
The literature support for the proposed regimen is based on several small studies or case series. dVenkatramani reproted four consecutive patients with multiply relapsed Wilms tumor who were treated with a combination of vincristine, irinotecan, temozolomide, and bevacizumab. Two had a complete response, and two had a partial response to treatment. Hematological toxicity and diarrhea were the main side effects. This regimen has activity in patients with multiply relapsed Wilms tumor without excessive toxicity, and should be evaluated further in this setting.
n 2010, McNall-Knapp and colleagues evaluated vincristine, irinotecan, temozolomide and an antibiotic in an extended phase I trial to examine tumor response and toxicity when the 3 agents were combined. The study also showed efficacy of using irinotecan, vincristine, and temozolomide together in pediatric relapsed solid tumors with response seen in 66% of patients. Wagner and colleagues, in 2010, conducted a phase I trial to evaluate vincristine, temozolomide, and two different cycle lengths of oral irinotecan (VOIT). A review bu Burke consuded that “Vincristine, irinotecan, temozolomide with or without bevacizumab possesses activity against relapsed solid pediatric tumors and represents an effective salvage regimen without overlapping DLTs.” The combination is supported by the current literature and is medically necessary.
3. If yes to question 2, please provide duration of therapy (24 months).
Note: If approving for a different duration then the standard duration provided by the client noted above, please indicate why in a brief sentence or two.
dVenkatramani R, Malogolowkin MH, Mascarenhas L.Treatment of multiply relapsed wilms tumor with vincristine, irinotecan, temozolomide and bevacizumab. Pediatr Blood Cancer. 2014 Apr;61(4):756-9.
Wagner, Lars, Turpin, John, et al. Pilot Study of Vincristine, Oral Irinotecan, and Temozolomide (VOIT Regimen) combined with Bevacizumab in Pediatric Patients with Recurrent Solid Tumors or Brain Tumors. Pediatr Blood Cancer. 2013;60;1447-1451.
E.Burke, Vincristine, Irinotecan, and Temozolomide Treatment with or without Bevacizumab in Pediatric Refractory/Recurrent Solid Tumors, JPurnla CLib Digest, 2014, http://pharmpractice.ku.edu/journal-club-digest/vincristine-irinotecan-and-temozolomide-treatment-or-without-bevacizumab