Cetuximab combined with paclitaxel or paclitaxel alone for patients with recurrent or metastatic head and neck squamous cell carcinoma progressing after EXTREME

Abstract

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A phase II trial of paclitaxel plus biweekly cetuximab for patients with recurrent or metastatic head and neck cancer previously treated with both platinum-based chemotherapy and anti-PD-1 antibody

“… 36 , 37 In addition, rechallenge of cetuximab with chemotherapy for patients with R/M-HNSCC showed better ORR than those who received chemotherapy without cetuximab (16.4%-33.3% versus 6.2%, respectively). 19 , 38 Consistent with these previous reports, rechallenge with cetuximab after PD-1 inhibitor appeared to yield a meaningful response in our study.…”

“… 16 , 17 , 18 By contrast, in a retrospective study, the efficacy of paclitaxel with or without cetuximab for platinum-refractory R/M-HNSCC was modest as compared with the first-line setting, with an ORR of 6.2%-30%, a median PFS of 2.5-4.2 months, and a median OS of 4.2-6.9 months. 2 , 19 , 20 Recently, retrospective studies have suggested that chemotherapy after immune checkpoint inhibitors showed better efficacy than a historical control of chemotherapy in the platinum-refractory setting. The ORR, median PFS, and median OS in such conditions were 30%-54%, 2.1-4.2 months, and 6.9-9.8 months, respectively.…”

Chemotherapy postimmunotherapy for recurrent metastatic head and neck squamous cell carcinoma

“…ORR was 30%, with 4% complete response (CR), and DCR was 57%. Nonetheless, the ORR is three to five times higher than ORR reported in second line for R/M HNSCC in a heavily treated population [7][8][9][10][11][12][13]16]. The combination of cetuximab þ taxane AE platinum was associated with higher ORR than other CT regimens (53% vs. 25%, P ¼ 0.024).…”

“…After first line, single agent with Methotrexate, Docetaxel, or EGFR inhibitor alone, were options with ORR ranging between 5% and 15%, median progression free survival (mPFS) between 2 and 6 months and median overall survival (mOS) between 6 and 7 months [7][8][9][10][11]. Noteworthy, the combination of Cetuximab with taxanes is associated with better outcomes than taxanes used alone [12,13].…”

Safety and preliminary activity of pembrolizumab‑carboplatin‑paclitaxel in heavily pretreated and/or fragile patients with PDL1‑positive recurrent/metastatic head and neck cancer

“…Hitt et al ( 32 ), in a phase II non-randomized trial demonstrated an ORR of 54% and a median PFS and OS of 4.2 months and 8.1 months, respectively, in patients treated with first-line wkPCx. In the second-line setting, Chevalier et al ( 33 ), reported an ORR of 16.4% and a 5.5-month median OS with wkPCx. In the Keynote-B10 study mentioned before, there were no differences between using three-weekly paclitaxel (175 mg/m 2 d1) and weekly paclitaxel (100 mg/m 2 d1,8), suggesting that weekly paclitaxel may be similar in terms of efficacy with a potentially more favourable toxicity profile ( 11 ).…”