metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
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 - 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