Table 4.

Patient-specific inferences and research design recommendations in eight clinical scenarios where adjuvant pembrolizumab is considered, based on KEYNOTE-564 (KN-564) [9] in patients harboring one of the three most common renal cell carcinomas (RCC). All patients are otherwise healthy and are interested in an absolute risk reduction (ARR) of at least 5% in two-year DFS probability with adjuvant pembrolizumab as estimated using the Assure prognostic nomogram [11].

Patient	RCC Histology	Eligible for KN-564	Age	Tumor Stage	Tumor Size (cm)	Fuhrman Nuclear grade	Necrosis	Renal Vein Invasion	Sarcomatoid features	Predicted 2-Year DFS with Surveillance	Predicted 2-Year DFS with Pembrolizumab	ARR	Recommend Adjuvant Pembrolizumab	External Observational Studies Needed	External Experimental Studies Needed
I	Clear cell	Yes	48	pT3a pN0 M0	10.6	4	Yes	Yes	Yes	41.1%	54.9%	13.5%	Yes	No	No
II	Clear cell	Yes	48	pT3a pN0 M0	7.0	2	No	Yes	No	87.2%	91.1%	3.9%	No	No	No
III	Clear cell	No	55	pT2b pN0 M0	10.3	3	Yes	No	No	68%	76.9%	8.9%	Yes	No	No
IV	Clear cell	Yes	52	pT3a pN0 M1 NED	10.2	3	No	Yes	No	Not estimable	Not estimable	Not estimable	Not estimable	Yes	No
V	Papillary type I	No	54	pT3a pN0 M0	13.9	2	No	Yes	No	94.6%	Not formally estimable but would be 97.3% even if HR = 0.5	Not formally estimable but would be 2.7% even if HR = 0.5	No	No	Yes
VI	Papillary type II	No	49	pT3 pN0 M0	10.4	4	Yes	Yes	Yes	41.4%	Not formally estimable but would be 47.7% even if hazard ratio (HR) = 0.84	Not formally estimable but would be 6.3% even if HR = 0.84	Not formally estimable but is a plausible recommendation under current state of knowledge	No	Yes
VII	Chromo-phobe	No	56	pT2a pN0 M0	9.5	Low grade	No	No	No	97.9%	Not formally estimable but would be 98.9% even if HR = 0.5	Not formally estimable but would be 1% even if HR = 0.5	No	No	Yes
VIII	Chromo-phobe	No	52	pT2b pN0 M0	11.4	High grade	No	No	Yes	Not estimable	Not estimable	Not estimable	Not estimable	Yes	Yes
pT2a: primary tumor >7 cm but ≤10cm in greatest dimension, limited to the kidney pT2b: primary tumor >10 cm in greatest dimension, limited to the kidney pT3a: primary tumor extends into the renal vein or its segmental (muscle containing) branches, or tumor invades perirenal and/or renal sinus fat (ie, perinephric fat), but not into the ipsilateral adrenal gland and not beyond Gerota’s fascia pN0: No regional lymph node metastasis M0: No history of radiologically visible distant metastasis M1 NED: History of radiologically visible distant metastasis with currently no evidence of disease