Fool’s gold, lost treasures, and the randomized clinical trial

BMC Cancer

Table 1 Differences in p values when using response vs PFS vs overall survival to assess association of outcomes with biomarkers

Agent	No. patients	P values^a
Agent	No. patients	Response	PFS	Survival
P values for differences in outcome for KRAS wild type vs KRAS mutant colorectal cancer patients treated with single agent monoclonal antibody:
Panitumumab [52]	427	<0.0001^b	<0.0001	>0.05
Cetuximab [53]	30	0.0003	NR^c	0.016
Cetuximab [54]	108	0.000001	0.074	0.020
P values for differences in outcome for KRAS wild type vs KRAS mutant colorectal cancer patients treated with combined monoclonal antibody and chemotherapy:
Cetuximab [55]	110	0.0024	0.0009	NR
Cetuximab [56]	69	0.021	0.021	0.15
Cetuximab [35]	256	0.03	0.04	0.06
Cetuximab [57]	540	0.03	0.07	0.44
Cetuximab [58]	88	0.024	0.003	0.0004
Cetuximab [59]	48	0.144	0.048	NR
Cetuximab [36]	315	<0.001	<0.001	0.12
Cetuximab [60]	67	0.07	0.14	0.047
Cetuximab [61]	1,063	0.0005	0.0028	0.0463
Cetuximab [62]	58	0.027	0.024	0.107
P values for differences in outcome for EGFR wild type vs EGFR mutant NSCLC patients treated with single agent tyrosine kinase inhibitor:
Gefitinib or erlotinib [63]	223	<0.0001^b	<0.0001	0.002
Gefitinib [64]	57	0.002	NR	0.11
Gefitinib [65]	100	0.0017	NR	0.0135
Gefitinib [66]	68	0.0001	NR	0.001
Gefitinib [67]	66	<0.0001	<0.0001	0.0001
Gefitinib [68]	83	0.001	0.002	0.02
Erlotinib [69]	36	0.006	NR	0.045
Erlotinib [70]	116	0.035	NR	0.47

a. Comparison of outcome in mutant vs wild type or p value for interaction between treatment arm on a comparative study and mutation status.
b. Calculated from published data using Fisher’s exact test.
c. NR = not reported.

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