Clinical Research
Copyright ©2006 Baishideng Publishing Group Co.
World J Gastroenterol. Nov 21, 2006; 12(43): 6973-6981
Published online Nov 21, 2006. doi: 10.3748/wjg.v12.i43.6973
Table 1 Randomized controlled trials (GEM combination vs GEM alone)
StudiesInterventionPatientsOS (d)6-mo survival (%)1-yr survival (%)6-mo TTP/PFS/TTF rate (%)ORR (CR + PR) %CBRJadad score
Scheithauer 2003[8]Gem4224659.437.224.6 (PFS)6/4210/303
Gem + Capecitabine4128567.731.836.97/4115/31
Colucci 2002[9]Gem5414031.51118 (TTP)5/4821/433
Gem + DDP532104711.32814/4520/38
Wang XY 2002[10]Gem20-81.331.3-1/1614/163
Gem + DDP22-61.611.1-2/1814/20
Gansauge 2002[11]Gem281443211-1/28-3
Gem + NSC-631570282796429-6/28-
Berlin 2002[12]Gem1621624215.532/160 (PFS)9/162-3
Gem + 5-FU1602015521.941/15811/160-
Bramhall 2002[13]Gem + placebo119164431723 (TTF)14/88-5
Gem + marimastat120165.547182911/97-
Cutsem 2004[14]Gem + placebo3471824924-28/347-5
3411935327-20/341-
Louvet 2005[15]Gem15621360.427.827.4 (PFS)27/15626.93
Gem1 + Oxaliplatin1572706834.74342/15738.2
Reilly 2004[16]Gem174186512127 (TTP)9/127-3
Gem + DX-8951f17520154233912/147-
Richards 2004[17]Gem28218950.920.127.6 (PFS)20/220-3
Gem + Pemetrexed28318650.921.432.142/230-
Li CP 2004[18]Gem2513820.313.611.8 (TTP)3/259/253
Gem + DDP2116831.16.311.82/216/21
Reni 2004[19]Gem47-63.921.312.9 (PFS)4/475/203
Gem + 5-FU + DDP + EPI52-64.638.537.420/5215/23
Viret 2004[20]Gem4120158.325.110 (TTF)2/41-3
Gem + DDP4224155.532.4143/42-
Rocha Lima 2004[21]Gem18019852.92221.9 (TTP)8/180-3
Gem + Irinotecan18018950.72130.629/180-
Costanzo 2001[22]Gem492175914.5-4/48-3
Gem + 5-FU442105923.3-5/43-
Heinemann 2003[23]Gem9718048.622.525.6 (TTP)8/93-3
Gem + DDP9522859.427.539.310/92-
Kulke 2004[24]Gem245-24/45----3
Gem + DDP45-23/45----
Gem + Docetaxel49-22/49----
Gem + Irinotecan44-21/44----
Richards 2002[25]Gem + Placebo8821362.920.425.9 (TTF)5/63-5
Gem + CI-9948619160.818.516.71/61-
Moore 2005[26]Gem + Erlotinib285191582432 (PFS)23/268-5
Gem + placebo28417749172521/262-
Stathopoulos 2005[27]Gem701955021.82-7/70-3
Gem + Irinotecan601926024.29-9/60-
Riess 2005[28]Gem236186532030 (TTP)17/236-3
Gem + 5-FU/CF230175.549202911/230-
Herrmann 2005[29]Gem157219622742 (PFS)12/1523-3
Gem + Capecitabine15925260314215/148-
Table 2 Toxic effects recorded from randomized controlled trials (Grade 3-4 toxic effects)
StudiesInterventionNeutrophilsPlateletsAnemiaInfectionNausea/vomitMucositisDiarrhea
Scheithauer2003[8]Gem3/391/3900000
Gem + Capecitabine4/4002/400002/40
Colucci 2002[9]Gem5/531/532/53-1/531/530
Gem + DDP9/511/513/51-1/5102/51
Wang XY 2002[10]Gem5/197/192/19-0--
Gem + DDP7/218/219/21-2/21--
Gansauge2002[11]Gem----3/28-1/28
Gem + NSC-631570----1/18-0
Berlin 2002[12]Gem8/15817/15816/158-30/1583/158/158
Gem + 5-FU11/15830/15816/158-29/1582/158/158
Bramhall 2002[13]Gem + placebo9/119-7/11912/11916/119--
Gem + marimastat3/120-3/12011/12013/120--
Cutsem 2004[14]Gem + placebo103/34241/34255/342-58/342-10/342
Gem + R115777132/33150/33166/331-46/331-13/331
Louvet 2005[15]Gem2/1565/15616/156-12/156-2/156
Gem + Oxaliplatin2/15722/15710/157-30/157-9/157
Reilly 2004[16]Gem24/1577/15713/157-17/157-2/157
Gem + DX-8951f50/16828/16811/168-33/168-6/168
Richards 2004[17]Gem35/27317/2738/273-18/273-2/273
Gem + Pemetrexed123/27349/27338/273-18/273-8/273
Li CP 2004[18]Gem2/251/252/25----
Gem + DDP4/215/212/21----
Reni 2004[19]Gem9/471/472/47-4/471/47-
Gem + 5-FU + DDP + EPI22/5215/522/52-3/522/52-
Viret 2004[20]Gem16/405/4011/40-3/40--
Gem + DDP23/4114/4114/41-9/41--
Rocha Lima 2004[21]Gem54/16924/16922/169-31/169-3/169
Gem + Irinotecan65/17334/17327/173-53/173-33/173
Costanzo 2001[22]Gem1/4903/49-000
Gem + 5-FU1/411/413/41-1/412/410
Heinemann 2003[23]Gem8/9710/9710/972/976/972/974/97
Gem + DDP10/954/9513/951/9521/954/953/95
Kulke 2004[24]Gem27/5815/586/586/5813/58-1/58
Gem + DDP29/6227/6211/622/6224/62-0/62
Gem + Docetaxel19/657/658/658/6510/65-5/65
Gem + Irinotecan12/609/604/604/6017/60-10/60
Moore2005[26]Gem + Erlotinib71/28228/28234/28245/28220/282<117/282
Gem + placebo73/28034/28034/28039/28020/28006/280
Stathopoulos 2005[27]Gem8/700/702/7001/7002/70
Gem + Irinotecan10/602/602/6001/6002/60
Riess 2005[28]Gem27/22515/22515/22519/22516/225-9/225
Gem + 5-FU/CF26/22028/22018/22012/22030/220-8/220
Herrmann 2005[29]Gem30/1537/1539/153-5/1531/1533/153
Gem + Capecitabine34/1558/1559/155-8/1550/1558/155
Table 3 Subgroup analyses on 6-mo survival rate
SubgroupsTrialsPatientsModeRD [95% CI]P
GEM plus targeted drug vs GEM alone[13, 14, 26]1496Fixed0.06 [0.01, 0.11]0.02
GEM plus DDP vs GEM alone[9, 10, 18, 20, 23, 24]560Fixed0.05 [-0.03, 0.13]0.24
GEM plus 5-FU vs GEM alone[12, 22, 28]881Random0.04 [-0.09, 0.17]0.57
GEM plus topoisomerase I inhibitor vs GEM alone[16, 21, 24, 27]928Fixed0.01 [-0.05, 0.08]0.72
GEM plus capecitabine vs GEM alone[8, 29]399Fixed0.00 [-0.08, 0.10]0.97