Table 1.
Study | Disease After Primary Therapy |
Treatment Regimens | No. | Median PFS | Median OS |
---|---|---|---|---|---|
Consolidation | |||||
Alberts 20066 | No pathologic evidence of disease (pCR) |
lnterferon-a every week, 6 weeks | 35 | 47 months | NR at 147 months |
Observation | 35 | 94 months | 87 months | ||
Barakat 199827 | pCR | Intraperitoneal cisplatin plus etopo side every 28 days, 3 cycles |
36 | NR, 61 % at 36 months | NA |
Observation | 46 | 28.5 months | NA | ||
Ben-Baruch 199428 Menczer 198929 |
pCR or clinical CR | Intraperitoneal cisplatin every 28 days, 3 cycles |
19 | 36 months | 60 months |
Radiotherapy | 18 | 23 months | 39 months | ||
Bolis 200630 | pCR or CR prior to second Look |
Epidoxorubicin, every 21 days, 4 Cycles |
64 | NA | 57.8% alive at 5 years |
No treatment | 74 | NA | 54.5% alive at 5 years | ||
Bruzzone 199031 | CR or SD | Continuation of initial front-line ther apy regimen, 3 courses |
21 | NR, 71.5% NED at 22 months | 48 months |
Radiotherapy | 20 | 16 months | 24 months | ||
De Placido 20048 | CR or PR | Topotecan, Days 1–5 every 3 weeks, 4Cycles |
137 | 18.2 months | NA |
Observation | 136 | 28.4 months | NA | ||
Goldberg 200132 | CR | Abdominal irradiation | 60 | NA | 30 months |
No treatment | 79 | NA | 41 months | ||
Goldhirsch 198833 | pCR | Whole abdominal radiotherapy | 24 | NR, 83% NED at 3 years | NA |
Any other treatment | 21 | 29.2 months | NA | ||
Gori 200534 | CR | Intraperitoneal cisplatin plus Hyperthermia |
29 | NA, 3.1% NED at 5 years | 64.4 months |
No treatment | 19 | NA, 3.7% NED at 5 years | 46.4 months | ||
Lambert 199335 | Residual disease <2 cm | Carboplatin, 5 cycles | 59 | NR, 76% NED at 5 years | 46 months |
Whole abdominal radiotherapy | 58 | 49 months | |||
Lee 200636 | CR | Paclitaxel plus cisplatin, 3 cycles | 42 | 25 months | 74.3 months |
Observation | 39 | 26 months | 78 months | ||
Menczer 199237 | CR | Intraperitoneal cisplatin every 28 days, 3 cycles |
25 | NA | 69.3 months |
No additional treatment | 12 | NA | 45.7 months | ||
Nicholson 199838 | pCR (experimental); pCR or CR (controls) |
Intraperitoneal radioimmunotherapy, HMFG1 labeled with yttrium-90 |
25 | NA | 94 months |
No radioimmunotherapy | 20 | NA | 60 months | ||
Nicoletto 200439 | pCR | 5-FU (for 5 days), followed by cispla tin (Day 6 or 7), every 28 days, 3 Cycles |
61 | 68 months | 87 months |
No treatment | 61 | 73 months | 89 months | ||
Oei 200740; Verheijen 200641 | No macroscopic disease at second look |
Intraperitoneal radioimmunotherapy, HMFG1 labeled with yttrium-90 |
224 | Mean, 64 months | NR, 68.7% alive at 3.5 years |
Standard treatment | 223 | Mean, 67 months | NR, 72.6% alive at 3.5 years | ||
Papadimitriou 200842 | CR | Cyclophosphamide plus melphalan | 37 | 7.1 years | 96 months |
Observation | 43 | 1.5 years | 73.2 months | ||
Piccart 200343 | pCR | Intraperitoneal cisplatin every 3 weeks, 4 cycles |
76 | 64 months | 117 months |
Observation | 76 | 40 months | 87 months | ||
Pickel 199944; Pickel 199145 | NED | Whole abdominal radiotherapy | 32 | 76 months | NR at 104 months |
No radiotherapy | 32 | 26 months | 40 months | ||
Sorbe 200346’47 (consolidation vs control) |
pCR | Abdominal radiotherapy | 32 | 116 months | 120 months |
No treatment | 31 | 32 months | 70.6 months | ||
Varia 200348 | pCR | Intraperitoneal radioactive Phosphorus |
104 | 43.3 months | 84 months |
No treatment | 98 | 32.9 months | 73 months | ||
Maintenance | |||||
Berek 200949; Berek 200450 Berek 200851 |
NED | Oregovomab every 4 weeks, 3 cycles, followed by every 12 weeks, up to 2 years |
73 | 13.3 months | 57.5 months |
Placebo | 72 | 10.3 months | 48.6 months | ||
Hall 200452; Hall, unpublished data |
NED | lnterferon-a-2a, 3 days every weeks | 89 | 14.4 months | 49 months |
Observation | 95 | 15.9 months | 38 months | ||
Hirte 200653 | NED, CR, and PR (residual dis ease <2 cm) |
Tanomastat | 122 | 10.4 months | 13.9 months |
Placebo | 121 | 9.2 months | 11.8 months | ||
Lawton 199054 | <2 cm residual disease | Chlorambucil every days, 14 days every 28 days, 12 cycles |
25 | 20.6 months | |
Total abdominal and pelvic radiotherapy |
25 | 15.5 months | |||
Markman 20037; Markman 200913 | CR | Paclitaxel every 28 days, 12 cycles | 150 | 22 months | 53 months |
Paclitaxel every 28 days, 3 cycles | 146 | 14 months | 48 months | ||
Micha 200614; Micha 200955; Micha 200556 |
CR | Paclitaxel every 21 days, 3 cycles | 13 | 11 months | 38 months |
Paclitaxel every 21 days, 12 cycles | 13 | 24 months | NR | ||
Pecorelli 200915 | pCR, CR | Paclitaxel every 21 days, 6 cycles | 101 | 34 months | 77 months |
Observation | 99 | 30 months | 84 months | ||
Sorbe 200346’47 (maintenance vs control) |
pCR | Carboplatin plus doxorubicin or epirubicin, 6 cycles |
35 | 37 months | 78 months |
No treatment | 31 | 32 months | 70.6 months | ||
Umesaki 199957 | pCRorCA 125 <8 U/mL | Cisplatin every day for 5 days, every 3–4 months, 3–5 years |
15 | NA | 79.3 months |
No treatment or <1 year of study treatment |
10 | NA | 67.4 months |
PFS indicates progression-free survival; OS, overall survival; pCR, pathologic complete response; NR, not reached; NA, not available; CR, complete response; SD, stable disease; NED, no evidence of disease; PR, partial response; HMFG1, human milk fat globulin 1; 5-FU, 5-fluorouracil.