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989P PHASE II STUDY OF COMBINATION CHEMOTHERAPY WITH<br />

ORAL S-1 AND OXALIPLATIN (SOX) IN PATIENTS WITH<br />

MUCINOUS ADENOCARCINOMA OF THE OVARY<br />

S. Nishio 1 , M. Shimada 2 , T. Kamura 1 , K. Ishitani 3 , K. Ochiai 4 , N. Takeshima 5 ,<br />

Y. Yokoyama 6 , H. Furumoto 7 , T. Sugiyama 8 , J. Kigawa 2<br />

1 Obstetrics and Gynecology, Kurume University School of Medicine, Kurume,<br />

JAPAN, 2 Obstetrics and Gynecology, Tottori University, Yonago, JAPAN,<br />

3 Obstetrics and Gynecology, Tokyo Women’s Medical University, Tokyo, JAPAN,<br />

4 Obstetrics and Gynecology, Jikei University School of Medicine, Tokyo, JAPAN,<br />

5 Gynecology, Cancer Institute Hospital, Tokyo, JAPAN, 6 Obstetrics and<br />

Gynecology, Hirosaki University Graduate School of Medicine, Hirosaki, JAPAN,<br />

7 Obstetrics and Gynecology, The University of Tokushima Graduate School,<br />

Tokushima, JAPAN, 8 Obstetrics and Gynecology, Iwate Medical University<br />

School of Medicine, Morioka, JAPAN<br />

We previously reported that patients with advanced or recurrent ovarian mucinous<br />

adenocarcinoma (MAC) had poor outcomes. Owing to similar biologic<br />

characteristics, chemo<strong>the</strong>rapy for MAC has been based on standard<br />

chemo<strong>the</strong>rapeutic regimens for colorectal cancer. Our basic studies also showed that<br />

a combination of oxaliplatin (L-OHP) and 5-fluorouracil was effective against MAC<br />

cells. This is <strong>the</strong> first phase II study of combination chemo<strong>the</strong>rapy with oral S-1 and<br />

L-OHP (SOX) in patients with advanced or recurrent MAC. From July 2008 through<br />

December 2011, 40 patients, including 16 with recurrent disease, were enrolled. Two<br />

patients could not receive SOX chemo<strong>the</strong>rapy because <strong>the</strong>ir performance status<br />

suddenly deteriorated after enrollment. L-OHP was administered at a dose of 100<br />

mg/m2 on day 1, and S-1 (80-120 mg/day) was given in 2 divided doses daily for 2<br />

weeks followed by a 1-week rest. This treatment schedule was repeated every 3 weeks<br />

until progressive disease. Tumor responses were evaluated according to <strong>the</strong> Response<br />

Evaluation Criteria in Solid Tumors, and toxicity was assessed with <strong>the</strong> Common<br />

Terminology Criteria for Adverse Events (version 3.0). Central pathological review<br />

(CPR) was also performed. On CPR, primary MAC was diagnosed in 13 patients,<br />

metastatic MAC in 15, endometrioid adenocarcinoma in 7, and o<strong>the</strong>r histological<br />

subtypes in 5. Of <strong>the</strong> 28 patients with a diagnosis of MAC, <strong>the</strong> objective response<br />

rate (RR) as assessed by an independent response review committee was 18%<br />

(complete response: 0, partial response: 5), and <strong>the</strong> disease control rate (CDR),<br />

including 14 patients with stable disease, was 68%. Among <strong>the</strong> 13 patients with<br />

primary MAC, <strong>the</strong> objective RR was 31%. Among <strong>the</strong> 38 patients who received SOX<br />

<strong>the</strong>rapy, 2 discontinued <strong>the</strong> regimen because of toxicity. Grade 3 or 4 hematologic<br />

toxicities were neutropenia (28%), anemia (21%), and thrombocytopenia (10%). The<br />

most common grade 3 or 4 nonhematologic toxicities were anorexia (8%) and<br />

hyponatremia (8%). The present study showed a promising RR and good tolerance,<br />

suggesting that SOX <strong>the</strong>rapy might contribute to prolonging survival.<br />

Disclosure: All authors have declared no conflicts of interest.<br />

990P ERCC1 EXPRESSION AS PREDICTIVE BIOMARKER FOR<br />

PLATINUM CONTAINING CHEMOTHERAPY REGIMENS IN<br />

OVARIAN CARCINOMA<br />

M. Ulker 1 , B.B. Duman 2 , B. Sahin 3 , D. Gumurdulu 4<br />

1 Intenal Medicine, Cukurova University Medical Faculty, Adana, TURKEY,<br />

2 Medical Oncology, Adana Numune Education and Research Hospital, Adana,<br />

TURKEY, 3 Medical Oncology, Cukurova University Medical Faculty, Adana,<br />

TURKEY, 4 Pathology, Cukurova University Medical Faculty, Adana, TURKEY<br />

Background and aims: Platin based chemo<strong>the</strong>rapy regimens are most important<br />

treatment choices for ovarian carcinoma. Significant numbers of patients develop<br />

resistance to platinum combination <strong>the</strong>rapies. We aimed to show <strong>the</strong> role of ERCC1<br />

expression in <strong>the</strong> resistance to <strong>the</strong>rapy in ovarian carcinoma.<br />

Patients and methods: Among all patients treated with platinum containing<br />

chemo<strong>the</strong>rapy regimens, 27 eligible ovarian cancer patients were selected. Tissue<br />

samples were obtained from paraffin blocks and evaluated ERCC1 expression with<br />

immunohistochemical method in <strong>the</strong> pathology department. Expression level 0, 1(+),<br />

2(+) was assessed as low expression, 3(+) was assessed as high expression. The results<br />

were correlated with clinical findings and <strong>the</strong>rapy response. Therapy response was<br />

assessed for RECIST criteria.<br />

Results: In this study 27 patients with pathologically proven ovarian cancer were<br />

enrolled to this study. Sixteen (59%) patients were stage III, and 11(41%) patients<br />

were stage IV. Complete response was determined in 18 (67%) patients, stable disease<br />

was determined in 3 (11%) patients and progressive disease was determined in 6<br />

(22%) patients. Median overall survival was 23 months. Treatment response rates<br />

were 50% in high ERCC1 expression group and 90% in low expression group.<br />

Statistically significant difference was found between two groups (p = 0.04). The<br />

median overall survival was 30 months(95% CI 23-37 months) in low ERCC1<br />

expression group and 15.8 months (95% CI 23-37 months) in high expression group<br />

(p = 0.183).<br />

Conclusion: Some primary tumors and most recurrent tumors develop drug<br />

resistance that lead to treatment failure. High ERCC1 expression levels are associated<br />

with <strong>the</strong> mechanism of cisplatin resistance in ovarian cancer. ERCC1 expression can<br />

be used as a predictive biomarker for <strong>the</strong> platin containing regimens in ovarian<br />

carcinoma.<br />

Disclosure: All authors have declared no conflicts of interest.<br />

Annals of Oncology<br />

991P PATTERNS AND OUTCOMES OF TREATMENT IN ELDERLY<br />

PATIENTS WITH OVARIAN CANCER: A RETROSPECTIVE<br />

MONO-ISTITUTIONAL STUDY<br />

M.O. Nicoletto 1 , L. Furini 1 , M. Dalla Palma 1 , L. Borgato 1 , P. Fiduccia 1 ,<br />

M. Rocchetto 2 , G.B. Nardelli 3 , M.T. Gervasi 4 , V. Zagonel 1<br />

1 Medical Oncology Unit 1, Istituto Oncologico Veneto, Padua, ITALY, 2 School of<br />

Medicine, University of Padua, School of Medicine, Padua, ITALY, 3 Deapartment<br />

of Gynecological Sciences and Human Reproduction, University of Padua,<br />

Padua, ITALY, 4 Ob/Gyn Unit Department for Health of Mo<strong>the</strong>rs and Children,<br />

Azienda Ospedaliera, Padua, ITALY<br />

Introduction: Ovarian cancer incidence is increasing in <strong>the</strong> elderly. We studied<br />

clinical and biological features of ovarian cancer in patients (OCP) aged >or = 70y.<br />

Methods: We conducted a retrospective analysis in 100 elderly OCP observed from<br />

1995 to 2011. We considered overall survival, comorbidities, surgery, hystotype and<br />

grading, chemo<strong>the</strong>rapy (monochemo<strong>the</strong>rapy vs polychemo<strong>the</strong>rapy), response to<br />

treatment, and toxicities.<br />

Results: Median age was 75y (range 70-88y). Most of <strong>the</strong> pts (82%) had advanced<br />

stage at diagnosis (stage III, 70.2%), serous ovarian cancer histotype (67%), and grade<br />

3 (74 pts, 78.7%). Most pts had at least one comorbidity (84%) and more than half<br />

(53.2%) two or more. 29.8% of pts received an optimal debulking ( 5cm) tumour burden at multiple sites, radiological evidence<br />

of serosal disease and half developed bowel obstruction whilst receiving<br />

chemo<strong>the</strong>rapy. Approximately 50% of patients presented with obstructive symptoms,<br />

but 25% presented with erratic bowel habit. Median survival following <strong>the</strong> first<br />

episode of bowel obstruction was 87 days (range 3-1754). Survival was similar<br />

between patients who underwent palliative surgery or chemo<strong>the</strong>rapy (p = 0.89).<br />

Median survival for patients presenting in bowel obstruction with platinum-sensitive<br />

(PS) and platinum-resistant (PR) disease (but not chemonaïve patients) who<br />

proceeded to chemo<strong>the</strong>rapy was prolonged compared with patients unsuitable for<br />

fur<strong>the</strong>r treatment (PS 191 vs. 24 days, p < 0.0001; PR 149 vs. 50 days, p = 0.06). A<br />

feasibility trial investigating <strong>the</strong> efficacy of low residue diet and intravenous<br />

ix326 | <strong>Abstract</strong>s Volume 23 | Supplement 9 | September <strong>2012</strong>

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