Is it better for industry or for patients to end an early oncology trial? (8)|palmerah.implantgigi.com

Treatment	Disease	Trial starting date versus end of the enrolment versus date of publication	DSMC	Primary end point versus end point used in interim analysis	Planned versus interim sample size	Rationale for planning interim analysis	Interim analysis consequences	Control group
Melphalan + prednisone + thalidomide^a	Multiple Myeloma	May 2000 versus August 2005 versus October 2007	Y	OS versus OS	500 versus 447 patients	No. of enrolled patients	Stop enrolment	A
Temsirolimus^a	Advanced renal cell carcinoma	July 2003 versus April 2005 versus May 2007	Y	OS versus OS	600 versus 446 events	No. of events	Disclosure of results	A
Sunitinib^a	Metastatic renal cell carcinoma	August 2004 versus October 2005 versus January 2007	Y	PFS versus PFS	471 events versus NA	Cut-off date	Crossover to treatment group	A
Sorafenib^a	Advanced clear-cell renal cell carcinoma	November 2003 versus March 2005 versus January 2007	Y	OS versus PFS	540 versus 363 events	No. of events	Crossover to treatment group + stop enrolment	P
Paclitaxel + carboplatin + bevacizumab^a	Non-small-cell lung cancer	July 2001 versus April 2004 versus December 2006	Y	OS versus OS	650 versus 455 events	No. of events	Disclosure of results	A
Lapatinib + capecitabine^a	HER-2-positive metastatic breast cancer	March 2004 versus NA versus December 2006	Y	TtP versus TtP	266 versus 114 events	No. of events	Crossover to treatment group + stop enrolment	A
Sunitinib^a	Advanced gastrointestinal stromal tumour	December 2003 versus January 2005 versus October 2006	Y	TtP versus TtP	281 versus 149 events	No. of events	Crossover to treatment group	P
FU + leucovorina + oxaliplatino (FOLFOX4)^a	Metastatic colorectal cancer	April 2001 versus April 2002 versus July 2006	Y	TtP versus TtP	550 versus 305 patients	No. of events	Stop enrolment	A
Uracil + tegafur	Stage III rectal cancer	October 1996 versus April 2001 versus April 2006	Y	RFS versus RFS and OS	400 versus 274 patients	Cut-off date	Disclosure of results	NT
Carboplatin	Epithelial ovarian cancer	November 1994 versus July 1998 versus January 2006	Y	TtP versus TtP	190 versus 120 events	No. of events	Stop enrolment	A
Methotrexate, vinblastine, doxorubicin/epirubicin, cisplatin	Advanced bladder cancer	May 1987 versus December 1990 versus January 2006	N	PFS versus PFS	NA	NA	Stop enrolment	NT
Trastuzumab + adjuvant chemotherapy^a	HER-2 positive breast cancer	May 2003 versus November 2004 versus October 2005	Y	DFS versus DFS	710 versus 394 events	No. of events	Stop enrolment + disclosure of results	A
Trastuzumab (1-year arm + 2-year arm)^a	HER-2-positive early-stage invasive breast cancer	December 2001 versus March 2005 versus October 2005	Y	DFS versus DFS	951 versus 347 events	No. of events	Disclosure of results	NT
Bevacizumab + (irinotecan, FU, leucovorin) and bevacizumab + (FU, leucovorin)^a	Metastatic colorectal cancer	NA versus NA versus May 2005	Y	OS versus OS	After 313 patients enrolled	No. of enrolled patients	Stop enrolment	A+ P
Letrozole^a	Adjuvant therapy in receptor-positive breast cancer	August 1998 versus September 2002 versus November 2003	Y	DFS versus DFS	515 versus 171 events	No. of events	Disclosure of results	P
Gemcitabine	Advanced or metastatic adenocarcinoma of the pancreas	December 1997 versus July 1999 versus September 2003	Y	OS versus OS and PFS	350 patients versus 140 events	No. of events	Stop enrolment + crossover to treatment group	A
Bevacizumab	Metastatic renal cell carcinoma	Oct 1998 versus Sep 2001 versus Jul 2003	Y	TtP, RR versus TtP	120 versus 110 patients	Cut-off date	Crossover to treatment group	P
Idoxifene	Postmenopausal metastatic breast cancer	December 1996 versus May 1999 versus February 2003	N	RR, TtP versus RR, TtP	440 versus 321 patients	No. of enrolled patients	Trial stopped for economic consideration	A
ChlVPP/EVA hybrid	Hodgkin's disease	September 1992 versus September 1996 versus July 2002	N	NA	80 versus 60 events	No. of events	Stop enrolment	A
Irinotecan + cisplatin	Metastatic small-cell lung cancer	November 1995 versus November 1998 versus January 2002	Y	OS versus OS	230 versus 230 patients	No. of enrolled patients	Stop enrolment	A
Vinblastine + doxorubicin + irradiation	Hodgkin's disease	NA versus April 2000 versus November 2001	Y	FFS versus FFS	420 versus 348 patients	No. of enrolled patients	Stop enrolment	A
Gemcitabine + vinorelbine	Advanced non-small-cell lung cancer	June 1997 versus May 1999 versus July 2000	Y	OS versus OS	240 versus 120 patients	No. of enrolled patients	Stop enrolment	A
Gemcitabine + vinorelbine + cisplatin	Advanced non-small-cell lung cancer	April 1997 versus April 1999 versus April 2000	N	OS versus OS	240 versus 120 patients	No. of enrolled patients	Stop enrolment	A
Lipiodol iodine-131	Adjuvant in resectable hepatocellular carcinoma	April 1992 versus August 1997 versus March 1999	N	Recurrence rate, recurrence sites, DFS, OS versus DFS	120 versus 43 patients	No. of enrolled patients	Stop enrolment	NT
Doxorubicin or ethoglucid	Adjuvant in superficial transitional cell bladder carcinoma	December 1979 versus December 1983 versus August 1997	N	NA	NA versus 206 patients	No. of enrolled patients	Stop enrolment	NT

Table 1

Summarised data on oncological trials (N=25) stopped early for benefit

Is it better for industry or for patients to end an early oncology trial? (8)

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