2. Platinum sensitivity status and median survival times in participants of included studies.
Platinum‐resistant data (PFI ≤6 months) | |||||||||
STUDY NAME | Other drug arm | PLD arm | N (other drug) | N (PLD) | Median TTP for other arm in weeks | Median TTP for PLD arm in weeks | Median TTD for other arm in weeks | Median TTD for PLD arm in weeks | Comment |
Colombo 2012 | PAT | PLD | 412 | 416 | 16 | 16 | 57 | 54 | 17% of these women had non‐measurable disease. |
Mutch 2007 | GEM | PLD | 99 | 96 | 15 | 13 | 54 | 58 | 36% of these women with non‐measurable disease. |
Gordon 2001 | TOP | PLD | 125 | 130 | 14 | 9 | 41 | 36 | It is unclear why survival in the PLD arm of this PR subgroup is so much shorter than that of the other trials. |
ASSIST‐3 2007 | CAN/carbo | PLD | NA | NA | 15 | 15 | NA | NA | Limited available data. Additional data were requested from Telik but not obtained. |
Kaye 2012 | OLA | PLD | 16 | 14 | NA | NA | NA | NA | Small study, subgroup data not available. |
MITO‐3 2008 | GEM | PLD | 43 | 43 | NA | NA | NA | NA | Subgroup data not available. |
PRECEDENT 2013 | EC145/PLD | PLD | 100 | 49 | 21 | 12 | 60 | 72 | Unpublished OS data. Study was not adequately powered to assess OS. |
OVA‐301 2010 | TBD/PLD | PLD | 118 | 124 | 17 | 16 | 61 | 53 | Subgroup analysis was pre‐planned for PFS but was exploratory for OS. |
ASSIST‐5 2010 | CAN/PLD | PLD | 65 | 60 | 24 | 16 | NA | NA | Pre‐planned subgroup analysis favoured the CAN/PLD group for PFS. Final OS results were not published. Additional data were requested from Telik but not obtained. |
Partially platinum‐sensitive data (PFI 6‐12 months) | |||||||||
CALYPSO 2010 | PAC/carbo | PLD/carbo | 183 | 161 | 38 | 40 | NA | NA | PFS HR = 0.73 (95% CI 0.58 to 0.90, P value 0.004) from Gladieff 2012; OS HR = 1.01 (0.80 to 1.28) from Wagner 2012. |
OVA‐301 2010 | TBD/PLD | PLD | 123 | 90 | 32 | 24 | 96 | 71 | TTP data from Poveda 2011 and exploratory TTD data from Monk 2012. PFS HR = 0.65 (95% CI 0.45 to 0.92; P value 0.015; OS HR =0.64 (95% CI 0.47 to 0.86; P value 0.0027). |
Platinum‐sensitive data (PFI > 6months) | |||||||||
Gordon 2001 | TOP | PLD | 111 | 109 | 23 | 29 | 70 | 108 | Exploratory analysis. The greatest effect was seen in the PPS subgroup (N=112; HR = 1.58, 95% CI 1.07‐2.34; P value 0.021). |
OVA‐301 2010 | TBD/PLD | PLD | 215 | 202 | 39 | 32 | 116 | 103 | Subgroup analysis was pre‐planned for PFS but was exploratory for OS. |
SWOG S0200 2008 | carbo | PLD/carbo | 30 | 31 | 34 | 51 | 77 | 133 | Small study which closed early. |
HeCOG 2010 | PAC/carbo | PLD/carbo | 96 | 93 | 46 | 51 | 126 | 106 | |
CALYPSO 2010 | PAC/carbo | PLD/carbo | 509 | 466 | 40 | 48 | 141 | 132 | |
Platinum‐resistant and platinum‐sensitive data combined | |||||||||
MITO‐3 2008 | GEM | PLD | 76 | 77 | 20 | 16 | 51 | 56 | PR + PPS. |
Kaye 2012 | OLA | PLD | 32 | 33 | 38 | 30 | NA | 76 | PR + PPS. Unpublished TTD data obtained from investigators. Phase II study not powered to assess survival. |
Gordon 2001 | TOP | PLD | 235 | 239 | 17 | 16.1 | 60 | 63 | PR + PS. |
O'Byrne 2002 | PAC | PLD | 107 | 107 | 22 | 22 | 56 | 46 | PR + PS; preliminary data. |
OVA‐301 2010 | TBD/PLD | PLD | 337 | 335 | 31 | 25 | 95 | 81 | PR + PS. |
Conversions from published data (months to weeks) were performed assuming one month to be 4.3 weeks, and then rounding the answer to the nearest week.
*This is from the comparison CAN versus active control (PLD and TOP data combined). The PLD group had an improved PFS compared with the TOP group but we were unable to obtain separate data.
Abbreviations: NA = not available; ; HR = hazard ratio; OS = overall survival; TTP = time to progression; TTD = time to death; PFI = platinum‐free interval; PR = platinum‐resistant (recurrence within 6 months of platinum‐based therapy); PPS = partially platinum‐sensitive (recurrence of 7 to 12 months of platinum‐based therapy); PS = platinum‐sensitive (recurrence >12 months after platinum‐based therapy); PRef = platinum‐refractory (recurrence within 1 month of, or during, platinum‐based therapy); PLD = pegylated liposomal doxorubicin; GEM = gemcitabine; TOP = topotecan; TBD = trabectedin; CAN = canfosfamide; PAT = patupilone; OLA = olaparib; PAC = paclitaxel; carbo = carboplatin