Back to Search
Start Over
Phase 1 study of nab-paclitaxel, cisplatin and 5-fluorouracil as induction chemotherapy followed by concurrent chemoradiotherapy in locoregionally advanced squamous cell carcinoma of the oropharynx
- Source :
- European Journal of Cancer. 50:2263-2270
- Publication Year :
- 2014
- Publisher :
- Elsevier BV, 2014.
-
Abstract
- Induction chemotherapy followed by concurrent chemoradiation (CRT) (sequential therapy) has been evaluated in the treatment of locoregionally-advanced squamous cell cancer of the head and neck (LA-SCCHN), with docetaxel, cisplatin (P) and 5-flurouracil (F) shown to be superior to PF doublet. Nab-paclitaxel (A) is a novel albumin-bound paclitaxel with a superior therapeutic index to docetaxel.A phase I trial [Clinical trials.gov identifier NCT00731380] to assess the safety and efficacy of nab-paclitaxel+cisplatin+5-fluorouracil (APF) as induction chemotherapy for three cycles, followed by concurrent carboplatin (area-under-curve (AUC) 1.5 weekly) with radiation therapy (RT) (70 Gy/35 fractions), was conducted using a 3+3 design in patients with previously untreated LA-SCCHN. Dose-limiting toxicities (DLTs) included: standard haematologic and non-haematologic toxicities, treatment delays, inability to complete ⩾95% of RT and skin/mucosal toxicity related to RT assessed from day 1 of treatment to 8 weeks after completion of CRT.17 patients with oropharyngeal cancer were enrolled in three dose levels, with 15 patients evaluable for DLT. The median age was 54 years (range, 44-65 years), 14 patients were male, and 11 patients' tumours were p16 positive and four negative. Grade 3/4 adverse events during APF (%total number of cycles) were hyponatraemia (14%) neutropenia (10%), lymphopaenia (4%) and thrombocytopenia (2%) during 49 evaluable APF cycles. Febrile neutropenia occurred during one cycle of treatment.The recommended phase 2 dose of APF is nab-paclitaxel 100mg/m(2) days 1 and 8, cisplatin 75 mg/mg(2) day 1 and 5-fluorouracil 1000 mg/m(2)/day×96 h days 1-4, every 3 weeks, for three cycles prior to CRT.
- Subjects :
- Adult
Male
Oncology
Cancer Research
medicine.medical_specialty
Paclitaxel
medicine.medical_treatment
chemistry.chemical_compound
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Animals
Humans
Aged
Cisplatin
Squamous Cell Carcinoma of Head and Neck
business.industry
Induction chemotherapy
Chemoradiotherapy
Induction Chemotherapy
Middle Aged
Carboplatin
Radiation therapy
Oropharyngeal Neoplasms
chemistry
Docetaxel
Head and Neck Neoplasms
Fluorouracil
Carcinoma, Squamous Cell
Female
business
medicine.drug
Subjects
Details
- ISSN :
- 09598049
- Volume :
- 50
- Database :
- OpenAIRE
- Journal :
- European Journal of Cancer
- Accession number :
- edsair.doi.dedup.....6a92d95d1926656a66d8491e9fdf93c3