INDUCTION CHEMOTHERAPY FOR CETUXIMAB FOR OVARIAN CANCER

Oncologist. 2015 Aug 24. pii: theoncologist.2015-0208. [Epub ahead of print]

A Randomized, Multicenter, Phase II Study of Cetuximab With Docetaxel and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Cancer.

Lee KW1, Koh Y2, Kim SB3, Shin SW4, Kang JH5, Wu HG6, Sung MW7, Keam B2, Kim DW2, Kim TM2, Kim KH7, Kwon TK7, Hah JH7, Kim IA6, Ahn SH8, Yoon DH3, Lee SW6, Kim SY9, Nam SY9, Jung KY10, Baek SK10, Hong SH5, Lee SH11, Heo DS2.

Author information

Abstract

LESSONS LEARNED: 

Addition of cetuximab may affect tolerability and, in turn, affect eventual outcomes.The incidence of prior human papillomavirus infection has emerged as an important variable that can confound trials enrolling patients with oropharyngeal cancer.

BACKGROUND: 

We investigated the efficacy of cetuximab when added to induction chemotherapy followed by concurrent chemoradiotherapy (CCRT) in patients with locally advanced head and neck squamous cell carcinoma.

METHODS: 

Patients were randomized to receive three cycles of docetaxel and cisplatin (TP regimen) with or without cetuximab (TP plus cetuximab [CTP] vs. TP) as induction chemotherapy. Patients in the CTP arm received CCRT with cetuximab and cisplatin, whereas patients in the TP arm received cisplatin alone. The primary endpoint was the objective response rate (ORR) after induction chemotherapy.

RESULTS: 

Overall, 92 patients were enrolled. The ORRs for induction chemotherapy in the CTP and TP arms were not different (81% vs. 82%). Adding cetuximab lowered the completion rate of induction chemotherapy and CCRT and resulted in more frequent dose reductions of the induction chemotherapy, although this did not reach statistical significance. In the CTP and TP arms, respectively, the 3-year progression-free survival (PFS) rates were 70% and 56% (p = .359), and the overall survival (OS) rates were 88% and 74% (p = .313). When limited to patients who completed induction chemotherapy, 3-year PFS rates of 78% and 59% (p = .085) and OS rates of 94% and 73% (p = .045) were observed in the CTP and TP arms, respectively.

CONCLUSION: 

Adding cetuximab to sequential treatment did not increase the treatment efficacy and resulted in greater toxicity. In the intent-to-treat population, neither PFS nor OS was improved by the addition of cetuximab to sequential treatment; however, a suggestion of improved survival outcomes was observed in patients completing cetuximab-containing induction chemotherapy.