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Docetaxel in Combination with Irinotecan (CPT-11) in Platinum-Resistant Paclixatel-Pretreated Ovarian Cancer

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Docetaxel in Combination with Irinotecan (CPT-11) in Platinum-Resistant Paclixatel-Pretreated Ovarian Cancer ANTICANCER RESEARCH 25: 3559-3564 (2005) Docetaxel in Combination with Irinotecan (CPT-11) in Platinum-resistant Paclixatel-pretreated Ovarian Cancer ARISTIDES POLYZOS1, CHRISTOS KOSMAS2, HELEN TOUFEXI1, NICHOLAS MALAMOS2, ANTONIOS LAGADAS1, CHRISTOS KOSMIDIS1, PANAGIOTIS GINOPOULOS3, NICHOLAS ZIRAS4, KOSTAS KANDILIS4 and VASSILIS GEORGOULIAS5 1Medical Oncology Unit, Laikon General Hospital, University of Athens School of Medicine; 2Medical Oncology Unit, Helena-Venizelou Hospital, Athens; 3Department of Medical Oncology, Agios Andreas Hospital, Patras; 4Department of Medical Oncology, Metaxa Cancer Hospital, Pireus; 5Department of Medical Oncology, University General Hospital Heraklion, Crete, Greece Abstract. The role of combination chemotherapy regimens (range, 2-17) and the median survival 11 months (range, 1- in the management of ovarian cancer patients with tumors 40); the 1-year survival was almost 50%. Myelotoxicity was resistant to platinum compounds has not yet been defined. moderate, with grade 3 and 4 neutropenia occurring in 23% This multicenter prospective phase II study evaluated the of the patients, grade 3-4 thrombocytopenia in 6% and activity and toxicity of the docetaxel-plus-irinotecan febrile neutropenia in 13%. Grade 3 diarrhea was observed combination in ovarian cancer patients whose tumors were in 2% of the patients. There was one treatment-related death resistant to platinum compounds and who had been exposed due to sepsis. In conclusion, the combination of docetaxel to paclitaxel. Treatment consisted of docetaxel 60 mg/m2 i.v. plus irinotecan with rhG-CSF support, appears to be a followed by irinotecan 200 mg/m2 i.v. both on day 1 followed moderately effective regimen with acceptable toxicity for by prophylactic recombinant human granulocyte-colony platinum-resistant, paclitaxel-pretreated ovarian cancer stimulating factor (rhG-CSF) support from days 2 to 6, every patients. Further investigation in comparative studies is 3 weeks. Thirty-one patients were enrolled in the study. The required to define the role of combination versus single agent median age was 60 years, and the median performance chemotherapy in this group of patients. status (ECOG) was 1. Eight (26%) patients had primary tumors resistant to platinum, while the rest of the population The standard front-line chemotherapy regimen for advanced had tumor recurrence within 6 months from the last cisplatin ovarian cancer is currently a combination of platinum agent treatment. Four chemotherapy cycles per patient were (cisplatin of carboplatin) and paclitaxel (1, 2). However, administered, with the delivered dose intensity at 75% of the despite the high response rate and prolonged median planned dose for both agents. Among 30 patients evaluable survival time observed with these regimens, over 80% of for response, there were 2 (7%) complete and 4 (14%) patients relapse requiring further treatment. Recurrent partial responses (overall response rate 20%; (95% disease is classified as being either sensitive or resistant to confidence interval, CI, 11%-33%). Stable disease was platinum compounds according to the time elapsed from the recorded in 8 (28%) patients and progressive disease in 15 last chemotherapy cycle and the disease relapse (3). (51%). The median response duration was 4.5 months Retreatment with cisplatin or carboplatin offers a response (range, 3-12), the median time to progression 5 months rate of 30% when the disease is considered potentially platinum-sensitive (4). For platinum-resistant disease, chemotherapy relies on other chemotherapeutic agents, such as topotecan, liposomal doxorubicin, gemcitabine, Correspondence to: Aristides Polyzos, MD, Assoc. Professor of vinorelbine or oxaliplatin that, as salvage treatment, yield Medicine, 1st Department of Propaedeutic Medicine, Laikon response rates between 10% and 30% (5-9). To date, taxane General Hospital, 17, Agiou Thoma St., Goudi, GR 11527, Athens, sensitivity or resistance has not been considered for the Greece. Tel: 0030-210-7706606, Fax: 0030-210-7791839, e-mail: r- [email protected] selection of a second-line treatment. Therefore, in order to establish an effective second-line chemotherapy regimen, it is Key Words: Docetaxel, irinotecan, cisplatin resistance, ovarian important to use agents which are not cross-resistant to the cancer. initial standard paclitaxel/platinum regimen. 0250-7005/2005 $2.00+.40 3559 ANTICANCER RESEARCH 25: 3559-3564 (2005) Docetaxel is a new taxane derived from the needles of concurrent infection, pre-existing diarrhea, intestinal paralysis or Taxus baccata. While it inhibits microtubule disassembly like obstruction. The study was approved by the Ethics and Scientific paclitaxel, it has different effects on Tau binding sites and Committees of the participating centers, and all patients gave their informed consent in order to participate in the study. on microtubule-associated proteins (9, 10). Docetaxel was found, in several in vitro and in vivo studies, to have a potent Treatment plan. Treatment was given on an outpatient basis and cytotoxic activity and an incomplete cross-resistance to comprised the administration of docetaxel (Taxotere®; Aventis paclitaxel (11, 12). This finding has been substantiated by Pharma, Bridgewater, USA) 60 mg/m2 followed by irinotecan the results of several phase II studies, which demonstrated (Campto®; Aventis Pharma) 200 mg/m2; both drugs were given as a the activity of docetaxel against paclitaxel-resistant tumors 1-hour i.v. infusion. The dose and schedule of drug administration in breast and ovarian cancer (13, 14). Furthermore, other were based on previous phase I, II studies (30). Antiemetic studies have shown the activity of docetaxel in platinum- treatment consisted of dexamethasone (8 mg) plus ondansetron (24 mg) given as i.v. bolus before chemotherapy. Premedication for resistant ovarian cancer (15-18). Similarly, topoisomerase I docetaxel hypersensitivity reactions and to prevent skin toxicity and inhibitors have been shown to display considerable activity fluid retention consisted of oral dexamethasone (8 mg) given 12, 8 against ovarian cancer. Topotecan has been considered an and 1 hour before docetaxel and 24, 36 and 42 hours post-infusion. effective agent in both the first- and second-line setting, in For the early cholinergic adverse effects induced by irinotecan combination with cisplatin (5, 19). Irinotecan hydrochloride administration, atropine (1 mg) was given subcutaneously, and for (CPT-11) is a semisynthetic, water-soluble derivative of the late diarrhea high-dose loperamide (4 mg initial dose, followed camptothecin, a plant alkaloid obtained from Camptotheca by 2mg every 2 hours until diarrhea-free) was administered. Recombinant human granulocyte-colony stimulating factor acuminata. Irinotecan, like topotecan, inhibits topo- (rhG-CSF) (Granocyte®; Aventis Pharma) (5 Ìg/kg/day) was given isomerase I, an intranuclear enzyme that relieves torsion in from days 2 to 6. The regimen was administered every 3 weeks for DNA induced by replication (20). Irinotecan has expressed a maximum of 6 cycles, unless there was evidence of disease significant in vitro and in vivo activity in several tumors, progression, unacceptable toxicity or patient refusal. Treatment including ovarian cancer (21-24). In clinical trials, its activity cycles were delayed for up to 2 weeks, unless the patient had was documented in both the first-and second-line setting in recovered from hematological and non-hematological toxicity. combination with cisplatin (25-28). Before the next course was started, the neutrophil count had to be ≥1.5x109/L and platelet ≥100x109/L with no diarrhea, and liver and It is interesting that, although combination chemotherapy renal function had to meet the eligibility criteria. The doses of both regimens have also been administered in ovarian cancer docetaxel and irinotecan were reduced by 25% in the event of grade patients with tumors resistant to platinum compounds, their 4 hematological toxicity. The irinotecan dose was reduced by 25% in efficacy and toxicity have not yet been defined (29). Based the event of ≥ grade 3 diarrhea. on these data, a prospective phase II study was conducted to evaluate the efficacy and toxicity of the docetaxel-plus- Patient evaluation. Baseline evaluations included: patient history, irinotecan combination as salvage treatment in ovarian physical examination, chest X-rays, complete blood count with cancer patients whose tumors were resistant to cisplatin and differential and platelet count, standard blood chemistry and ECG. Computed tomography (CT) scans of the chest, abdomen, who had been pretreated with paclitaxel. pelvis and whole body bone scintigraphy were performed at study entry and CT scan of the brain whenever clinically Patients and Methods indicated. Complete blood counts with differential and platelet counts were performed twice weekly or daily in case of grade 3/4 Patient population. Patients were required to have: a) histologically neutropenia, thrombocytopenia or febrile neutropenia until confirmed epithelial ovarian carcinoma with manifestations of hematological recovery; blood chemistry and physical locoregional or metastatic bidimensionally measurable disease; b) examination were performed every 3 weeks. Patients were either primary tumors resistant (non-responding or progressing) to evaluated before each cycle for lesions assessable by physical platinum-based combinations or recurring within 6 months from examination. Pelvic examination was performed
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