Carboplatin/paclitaxel versus cisplatin/paclitaxel as first-line chemotherapy in advanced ovarian cancer: an interim analysis of a randomized phase III trial of the Arbeitsgemeinschaft Gynäkologische Onkologie Ovarian Cancer Study Group.
Since publication of the results of the Gynecologic Oncology Group III study, the combination of cisplatin/paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) has been widely adopted as standard treatment for advanced ovarian cancer. Further attempts to optimize first-line chemotherapy with platinum and taxanes include the substitution of cisplatin with carboplatin, individualization of the carboplatin dose by calculating it according to the area under the concentration-time curve, and reduction of paclitaxel infusion duration. These attempts have led to the initiation of several phase I/II trials evaluating the combination of carboplatin/paclitaxel. The promising results of these small studies have prompted the initiation of three phase III trials comparing carboplatin/paclitaxel with the standard combination of cisplatin/paclitaxel. The interim analysis after 15 months' accrual of the prospectively randomized German Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) study is presented here. As of January 1997, 518 of 660 planned patients have been recruited. The interim analysis is based on data from 449 evaluable patients. The preliminary data indicate that hematologic toxicity occurred more frequently in arm A (carboplatin/paclitaxel), whereas nonhematologic toxicity occurred slightly more frequently in arm B (cisplatin/paclitaxel). Dose-intensity analysis did not reveal cumulative dose reductions or an increased need for colony-stimulating factors over subsequent courses in both arms. Forty-four patients with measurable disease following surgery completed chemotherapy and were evaluable for response, which remains blinded at this time and is reported for the group as a whole. So far, there have been 18 complete responses (41%) and 15 partial responses (34%), for an overall response rate of 75%. Retrospective comparison reveals no significant difference in response rates between patients in the cisplatin/paclitaxel arm of Gynecologic Oncology Group III and those in the Arbeitsgemeinschaft Gynäkologische Onkologie study. Overall, this interim analysis did not reveal any reason for an early termination of this study. Accrual is ongoing and is expected to be completed this year.
du Bois
A
A
St Vincentius Krankenhäuser, Karlsruhe, Germany.
Lück
H J
HJ
Meier
W
W
Möbus
V
V
Costa
S
S
Richter
B
B
Warm
M
M
Bauknecht
T
T
Schröder
W
W
Olbricht
S
S
Nitz
U
U
Jackisch
C
C
D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D019540:Area Under Curve; D018771:Arthralgia / Q000139:chemically induced; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D005858:Germany; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D018365:Neoplasm, Residual; D009503:Neutropenia / Q000139:chemically induced; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000601:surgery; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D010146:Pain / Q000139:chemically induced; D018579:Patient Selection; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced; D011446:Prospective Studies; D011788:Quality of Life; D012074:Remission Induction; D012189:Retrospective Studies; D016037:Single-Blind Method; D015996:Survival Rate; D013921:Thrombocytopenia / Q000139:chemically induced; D014839:Vomiting / Q000139:chemically induced
D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D016190:Carboplatin; D017239:Paclitaxel