Table 2. Description of RCTs.
| Study | No. of patients | Experimental regimen | Study phase | Primary Endpoint | ITT analysis | Post-protocol treatment |
|---|---|---|---|---|---|---|
| RCTs comparing DOX and DOX-based combination chemotherapy | ||||||
| Chang 1976 [17] | 33 | DOX+Streptozotocin | not specified | not specified | not specified | not specified |
| Schoenfeld 1982 [18] | 221 | 1) VCR+DOX+CPA 2) VCR+Act-D+CPA |
not specified | not specified | not specified | Crossover |
| Omura 1983 [19] | 315 | DOX+DTIC | not specified | not specified | not specified | not specified |
| Muss 1985 [20] | 132 | DOX+CPA | III | not specified | not specified | not specified |
| Borden 1987 [21] | 361 | DOX+DTIC | not specified | not specified | not specified | not specified |
| Borden 1990 [22] | 347 | DOX+Vindesine | not specified | not specified | not specified | not specified |
| Edmonson 1993 [23] | 279 | 1) DOX+IFM 2) DOX+MMC+CDDP |
III | not specified | not specified | not specified |
| Santoro 1995 [24] | 663 | 1) DOX+IFM 2) CYVADIC |
III | not specified | not specified | not specified |
| Maurel 2009 [25] | 132 | DOX+IFM | II | PFS | not specified | IFM, DTIC, GEM+DTIC |
| Demetri 2012 [26] | 128 | DOX+Conatumumab | II | PFS | not specified | Roll over |
| Judson 2014 [27] | 455 | DOX+IFM | III | OS | + | DOX, EPI, IFM, TRAB, PAZ, ERIB, DTIC, GEM+DOC, etc |
| Tap 2016 [10] | 133 | DOX+Olaratumab | II | PFS | + | DOX, GEM+DOC, TRAB, PAZ, ERIB, GEM, DTIC, DOC, etc |
| Martin-Broto 2016 [13]) | 115 | DOX+TRAB | II | PFS | + | not specified |
| Tap 2017 [28] | 640 | DOX+Evofosfamide | III | OS | + | DOX, IFM, TRAB, GEM+DOC, PAZ, ERIB, GEM, DTIC, etc |
| RCTs comparing DOX and other chemotherapy without DOX | ||||||
| Cruz1979 [29] | 117 | 1) Act-D+LPAM 2) Act-D+LPAM+VCR 3) Act-D+LPAM+NSC1026 |
III | not specified | not specified | Crossover |
| Savlov 1981 [30] | 208 | Cycloleucine | not specified | not specified | not specified | Crossover |
| Bramwell 1983 [31] | 71 | Carminomycin | II | not specified | not specified | Crossover |
| Mouridsen 1987 [32] | 210 | EPI | II/III | not specified | not specified | Crossover |
| Nielsen 1998 [33] | 334 | EPI | III | not specified | not specified | not specified |
| Verweij 2000 [34] | 86 | DOC | II | not specified | not specified | Crossover |
| Judson 2001 [35] | 95 | Liposomal doxorubicin | II | RR | + | not specified |
| Lorigan 2007 [36] | 326 | IFM | III | PFS | not specified | not specified |
| Gelderblom 2014 [37] | 118 | Brostallicin | II | 26-week PFR | not specified | DOX-based, IFM, etc |
| Blay 2014 [11] | 121 | TRAB | III | PFS | + | TRAB, etc |
| Bui-Nguyen 2015 [12] | 133 | TRAB | II | PFS | + | not specified |
| Chawla 2015 [38] | 123 | Aldoxorubicin | II | PFS | + | not specified |
| Seddon 2017 [39] | 257 | GEM+DOC | III | 24-week PFR | + | DOX, IFM, TRAB, PAZ, GEM+DOC, GEM, etc |
Abbreviations: RCT, randomized controlled trial; OS, overall survival; PFS, progression-free survival; PFR, progression-free rate; RR, response rate; ITT, intention-to-treat; DOX, doxorubicin; VCR, vincristine; CPA, cyclophosphamide; Act-D, actinomycin D; DTIC, dacarbazine; IFM, ifosfamide; MMC, mitomycin C; CDDP, cisplatin; CYVADIC, CPA+VCR+DOX+DTIC; TRAB, trabectedin; LPAM, melphalan; EPI, epirubicin; DOC, docetaxel; GEM, gemcitabine; PAZ, pazopanib; ERIB, eribulin.