metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
mHNSCC - L1 - PDL1 positive metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 1st line (L1) mHNSCC - L1 - PDL1 positive
versus cetuximab plus platin plus 5FU
	pembrolizumab alone
	KEYNOTE-048 (P vs C ; CPS > 20), 2019 Lancet 2019; 394:1915-1928 Adv Ther 2021 Apr 15. NCT02358031	RCT	mHNSCC - L1 - PDL1 positive	pembrolizumab	cetuximab with chemotherapy (platine plus 5FU)	patients with recurrent or metastatic squamous cell carcinoma of the head and neck, untreated locally incurable recurrent or metastatic HNSCC	133 / 122	some concern	conclusif	demonstrated 39 % decrease in deaths (OS) (PE) inconclusive 1 % decrease in progression or deaths (PFS) (PE) suggested 42 % decrease in deaths (OS) (extension) statistically significant 89 % decrease in objective responses (ORR)
	KEYNOTE-048 (P vs C ; CPS > 1), 2019 Lancet 2019; 394:1915-1928 Adv Ther 2021 Apr 15. NCT02358031	RCT	mHNSCC - L1 - PDL1 positive	pembrolizumab	platinium based chemotherapy (cetuximab plus 5FU and platine)	patients with recurrent or metastatic squamous cell carcinoma of the head and neck, untreated locally incurable recurrent or metastatic HNSCC	257 / 255	some concern	conclusif	demonstrated 22 % decrease in deaths (OS) (PE) inconclusive 16 % increase in progression or deaths (PFS) (PE) suggested 26 % decrease in deaths (OS) (extension) statistically significant 56 % decrease in objective responses (ORR)
	pembrolizumab plus 5FU plus platin
	KEYNOTE-048 (PC vs C ; CPS > 20), 2019 Lancet 2019; 394:1915-1928 Adv Ther 2021 Apr 15. NCT02358031	RCT	mHNSCC - L1 - PDL1 positive	pembrolizumab plus 5FU plus platine	cetuximab plus 5FU plus platine	patients with recurrent or metastatic squamous cell carcinoma of the head and neck, untreated locally incurable recurrent or metastatic HNSCC	126 / 110	some concern	conclusif	demonstrated 40 % decrease in deaths (OS) (PE) suggested 27 % decrease in progression or deaths (PFS) (PE)
	KEYNOTE-048 (PC vs C ; CPS > 1), 2019 Lancet 2019; 394:1915-1928 Adv Ther 2021 Apr 15. NCT02358031	RCT	mHNSCC - L1 - PDL1 positive	pembrolizumab plus 5FU plus platine	cetuximab plus 5FU plus platine	patients with recurrent or metastatic squamous cell carcinoma of the head and neck, untreated locally incurable recurrent or metastatic HNSCC	242 / 226	some concern	conclusif	demonstrated 37 % decrease in deaths (OS) (PE) inconclusive 18 % decrease in progression or deaths (PFS) (PE)