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Phase II Trial on Cisplatin-Adriamycin-Paclitaxel Combination as Neoadjuvant Chemotherapy for Locally Advanced Cervical Adenocarcinoma

Lorusso, Domenica MD; Ramondino, Stefano MD; Mancini, Maria MD; Zanaboni, Flavia MD; Ditto, Antonino MD; Raspagliesi, Francesco PhD

International Journal of Gynecological Cancer: May 2014 - Volume 24 - Issue 4 - p 729–734
doi: 10.1097/IGC.0000000000000115
Cervical Cancer

Objective Neoadjuvant chemotherapy (NACT) followed by surgery is a different therapeutic approach to locally advanced cervical adenocarcinoma (LACA) and seems to offer specific advantages over chemoradiation. This phase II trial was designed to evaluate the toxicity and activity of NACT with cisplatin-adriamycin-paclitaxel (TAP) in patients with LACA.

Methods Patients with International Federation of Gynecology and Obstetrics stage IB2–IIB uterine adenocarcinoma were treated with NACT TAP for 3 cycles. After the last cycle, patients underwent radical surgery with lymph node dissection. Pathological response was classified as no residual tumor (pCR), residual disease with less than 3-mm stromal invasion (pR1), or residual disease with more than 3-mm stromal invasion (pR2).

Results Between 2003 and 2010, 30 women were enrolled. Fourteen complete clinical responses, 10 partial responses, and 6 stabilizations of disease were registered. Three patients achieved a pCR, 6 a pR1 response, and 21 a pR2 response. At a median follow-up of 45 months, progression-free survival and overall survival were 37 and 48 months, respectively. Hematologic toxicity was the most relevant adverse effect.

Conclusions The TAP combination seems to be feasible with an acceptable toxicity profile and a promising response rate for the treatment of LACA.

Department of Gynecologic Oncology, Fondazione “IRCCS” National Cancer Institute, Milan, Italy.

Address correspondence and reprint requests to Domenica Lorusso, MD, Gynecologic Oncology Unit, Fondazione “IRCCS” National Cancer Institute, Via Venezian 1 20133 Milan, Italy. E-mail:

This article has not been supported by any pharmaceutical or industry or health organizations.

The authors declare no conflicts of interest.

Received March 20, 2013

Accepted January 21, 2014

© 2014 by the International Gynecologic Cancer Society and the European Society of Gynaecological Oncology.