Phase II evaluation of neoadjuvant chemotherapy and debulking followed by intraperitoneal chemotherapy in women with stage III and IV epithelial ovarian, fallopian tube or primary peritoneal cancer: Southwest Oncology Group Study S0009.

Abstract

OBJECTIVE:

Intraperitoneal (IP) chemotherapy prolongs survival in optimally reduced ovarian cancer patients. For patients in whom optimal debulking cannot be achieved, one could incorporate IP therapy post-operatively if the cancer was optimally debulked following neoadjuvant chemotherapy. We sought to evaluate overall survival (OS), progression-free survival (PFS), percent of patients optimally debulked and toxicity in patients treated with this strategy.

METHODS:

Women with adenocarcinoma by biopsy or cytology with stage III/IV (pleural effusions only) epithelial ovarian, fallopian tube or primary peritoneal carcinoma that presented with bulky disease were treated with neoadjuvant intravenous (IV) paclitaxel 175 mg/m2 and carboplatin AUC 6 q 21 daysx3 cycles followed by surgery (if >/=50% decrease in CA125). If optimally debulked they received IV paclitaxel 175 mg/m2 and IP carboplatin AUC 5 (day 1) and IP paclitaxel 60 mg/m2 (day 8) q 28 daysx6 cycles.

RESULTS:

Sixty-two patients were registered. Four were ineligible. Fifty-six were evaluated for neoadjuvant chemotherapy toxicities. One patient died of pneumonia. Five patients had grade 4 toxicity, including neutropenia (3), anemia, leukopenia, anorexia, fatigue, muscle weakness, respiratory infection, and cardiac ischemia. Thirty-six patients had debulking surgery. Two had grade 4 hemorrhage. Twenty-six patients received post-cytoreduction chemotherapy. Four had grade 4 neutropenia. At a median follow-up of 21 months, median PFS is 21 months and median OS is 32 months for all 58 patients. PFS and OS for the 26 patients who received IV/IP chemotherapy is 29 and 34 months respectively.

CONCLUSIONS:

These results compare favorably with other studies of sub-optimally debulked patients.

• Authors: Amy D Tiersten, P Y Liu, Harriet O Smith, Sharon P Wilczynski, William R Robinson 3rd, Maurie Markman, David S Alberts
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 112 Issue 3 Pg. 444-9 (Mar 2009) ISSN: 1095-6859 [Electronic] United States
• PMID: 19138791 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Carboplatin
• Paclitaxel

Topics

• Adenocarcinoma (drug therapy, pathology, surgery)
• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage)
• Carboplatin (administration & dosage)
• Disease-Free Survival
• Fallopian Tube Neoplasms (drug therapy, pathology, surgery)
• Female
• Humans
• Infusions, Parenteral
• Middle Aged
• Neoadjuvant Therapy
• Neoplasm Staging
• Ovarian Neoplasms (drug therapy, pathology, surgery)
• Paclitaxel (administration & dosage)
• Peritoneal Neoplasms (drug therapy, pathology, surgery)