metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
mHNSCC - L1 - all population metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 1st line (L1) mHNSCC - L1 - all population
versus cetuximab plus platin plus 5FU
	pembrolizumab alone
	KEYNOTE-048 (P vs C ; all population), 2019 Lancet 2019; 394:1915-1928 Adv Ther 2021 Apr 15. J Clin Oncol 2022; 40:2321-2332-. NCT02358031	RCT	mHNSCC - L1 - all population	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	301 / 300	some concern	inconclusive	suggested 17 % decrease in deaths (OS) (PE) statistically significant 34 % increase in progression or deaths (PFS) (PE) statistically significant 64 % decrease in objective responses (ORR)
	pembrolizumab plus 5FU plus platin
	KEYNOTE-048 (PC vs C ; all population), 2019 Lancet 2019; 394:1915-1928 Adv Ther 2021 Apr 15. NCT02358031	RCT	mHNSCC - L1 - all population	pembrolizumab plus 5 FU plus platine	cetuximab plus 5 FU plus platine	patients with recurrent or metastatic squamous cell carcinoma of the head and neck, untreated locally incurable recurrent or metastatic HNSCC	281 / 278	some concern	conclusif	demonstrated 23 % decrease in deaths (OS) (PE) inconclusive 8 % decrease in progression or deaths (PFS) (PE) suggested 28 % decrease in deaths (OS) (extension)
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)
mHNSCC - L2 - all population metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - all population
versus Standard of Care (SoC)
	durvalumab alone
	EAGLE (D vs ICC), 2019 Journal of Clinical Oncology Ann Oncol 2020 Jul;31(7):942-950. NCT02369874	RCT	mHNSCC - L2 - all population	durvalumab	investigator’s choice: cetuximab, taxane, methotrexate, or fluoropyrimidine-based regimen	patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).of the oral cavity, oropharynx, hypopharynx, or larynx not amenable to curative therapy who had progression or recurrence during or after only one systemic treatment regimen containing a platinum agent	240 / 249	some concern	inconclusive	inconclusive 12 % decrease in deaths (OS),deaths (OS) (PE)
	durvalumab plus tremelimumab
	EAGLE (DT vs ICC), 2019 Journal of Clinical Oncology Ann Oncol 2020 Jul;31(7):942-950. NCT02369874	RCT	mHNSCC - L2 - all population	durvalumab plus tremelimumab	investigator’s choice: cetuximab, taxane, methotrexate, or fluoropyrimidine-based regimen	patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).of the oral cavity, oropharynx, hypopharynx, or larynx not amenable to curative therapy who had progression or recurrence during or after only one systemic treatment regimen containing a platinum agent	247 / 249	some concern	inconclusive	inconclusive 4 % increase in deaths (OS),deaths (OS) (PE)
	nivolumab alone
	CheckMate 141, 2016 Oral Oncol 2017;73:138-146 Lancet Oncol 2017;18:1104-1115 Oral Oncol. 2018; 81:45-51 Oncologist 2018; 23:1079-1082 Cancer 2019; 125:3208-3218 Clin Cancer Res 2019; 25:5221-5230 Pharmacoeconomics 2019; 37:1041-1047 N Engl J Med. 2016 Nov 10;375(19):1856-1867 NCT02105636	RCT	mHNSCC - L2 - all population	nivolumab	ICC (methotrexate, docetaxel or cetuximab)	patients with recurrent squamous-cell carcinoma of the head and neck whose disease had progressed within 6 months after platinum-based chemotherapy	240 / 121	some concern	conclusif	demonstrated 30 % decrease in deaths (OS) (PE) suggested 32 % decrease in deaths (OS) (extension)
	pembrolizumab alone
	KEYNOTE-040 (all population), 2018 Lancet 2019; 393:156-167 BMJ Open 2020 Dec 18;10(12):e038867. J Immunother Cancer 2019 Apr 3;7(1):96. Mod Pathol 2020 Nov 25. NCT02252042	RCT	mHNSCC - L2 - all population	pembrolizumab	chemotherapy (methotrexate, docetaxel or cetuximab)	patients with recurrent or metastatic head and neck squamous cell cancer that progressed during or after platinum-containing treatment : all population	247 / 248	some concern	conclusif	demonstrated 20 % decrease in deaths (OS) (PE)
mHNSCC - L2 - PDL1 negative metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - PDL1 negative
versus durvalumab alone
	durvalumab plus tremelimumab
	CONDOR (DT vs D ; PDL1 TC<25%), 2019 JAMA Oncol 2019; 5:195-203 NCT02319044	RCT	mHNSCC - L2 - PDL1 negative	durvalumab plus tremelimumab	durvalumab monotherapy	patients with recurrent or metastatic HNSCC (PD-L1-low/negative) that had progressed after 1 platinum-containing regimen in the R/M setting	133 / 67	high	inconclusive	inconclusive 17 % decrease in objective responses (ORR) (PE) statistically significant 8.4-fold increase in STRAE (any grade)
versus tremelimumab
	durvalumab plus tremelimumab
	CONDOR (DT vs T ; PDL1 TC<25%), 2019 JAMA Oncol 2019; 5:195-203 NCT02319044	RCT	mHNSCC - L2 - PDL1 negative	durvalumab plus tremelimumab	tremelimumab monotherapy	patients with recurrent or metastatic HNSCC (PD-L1-low/negative) that had progressed after 1 platinum-containing regimen in the R/M setting	133 / 67	high	suggested	inconclusive 4.2-fold increase in objective responses (ORR) (PE)
mHNSCC - L2 - PDL1 positive metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - PDL1 positive
versus Standard of Care (SoC)
	pembrolizumab alone
	KEYNOTE-040 (CPS >1), 2018 Lancet 2019; 393:156-167 BMJ Open 2020 Dec 18;10(12):e038867. J Immunother Cancer 2019 Apr 3;7(1):96. Mod Pathol 2020 Nov 25. NCT02252042	RCT	mHNSCC - L2 - PDL1 positive	pembrolizumab	chemotherapy (methotrexate, docetaxel or cetuximab)	patients with recurrent or metastatic head and neck squamous cell cancer that progressed during or after platinum-containing treatment : only patients with CPS > 1	196 / 191	some concern	conclusif	demonstrated 26 % decrease in deaths (OS) (PE)

mHNSCC - L1 - all population metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 1st line (L1) mHNSCC - L1 - all population

mHNSCC - L1 - PDL1 positive metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 1st line (L1) mHNSCC - L1 - PDL1 positive

mHNSCC - L2 - all population metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - all population

mHNSCC - L2 - PDL1 negative metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - PDL1 negative

mHNSCC - L2 - PDL1 positive metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - PDL1 positive