Risk group criteria for tailoring adjuvant treatment in patients with endometrial cancer : a validation study of the GOG criteria

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MOLECULAR AND CLINICAL ONCOLOGY 5: , 2016

Study Title The SACS trial - Phase II Study of Adjuvant Therapy in CarcinoSarcoma of the Uterus

Cancer of the corpus uteri

Transcription:

Risk group criteria for tailoring adjuvant treatment in patients with endometrial cancer : a validation study of the GOG criteria Suk-Joon Chang, MD, Hee-Sug Ryu MD Gynecologic Cancer Center Department of Obstetrics and Gynecology Ajou University School of Medicine Suwon, Korea

Disclosure No relevant conflict of interests to disclose

Adjuvant treatment in patients with endometrial cancer Surgically staged endometrial cancer patients can be classified into three categories. - Low risk - Intermediate risk - High risk Adjuvant treatment is given to patients with intermediate- to high-risk tumors. - Radiotherapy - Chemotherapy (Morrow et al, 1991; Fanning, 2001; Odagiri et al, 2011; Kong et al, 2013)

Criteria for risk group Criteria for risk group : comparison of clinical trial inclusion criteria of PORTEC-1,2 and GOG 99. Low risk FIGO stage IA Intermediate risk FIGO stage IB, stage IC, stage II High-intermediate risk GOG 99 PORTEC-1,2 Any age and : Age > 60 years and (1) G2-3 (1) Stage IC G1/2 (2) LVSI (+) (2) Stage IB G3 (3) Outer third invasion Any age, stage IIA Age 50-69 years, with 2 of 3 of the above listed factors Age 70 years, with 1 of 3 of the above listed factors High risk FIGO stage III, stage IV Serous or clear cell histology (Creutzberg et al, 2000; Fanning, 2001; Keys et al, 2004; Nout et al, 2010)

Some considerations The FIGO staging system was revised in 2009 and the current criteria based on the 1988 FIGO staging system did not fit in well with the updated staging system. High-intermediate risk criteria of GOG 99 seem to be so complicated and those of PORTEC seem to be incomplete because of lacking LVSI and LN status.

Objective The purpose of this study is to validate the previous risk criteria of GOG 99 for adjuvant treatment and to evaluate the novel risk criteria predicting the prognosis and tailoring adjuvant treatment in patients with endometrial cancer who underwent complete surgical staging procedures.

Methods Retrospective study 2000.01~2013.02 261 consecutive patients with surgically staged endometrial cancer - Total hysterectomy, adnexectomy, peritoneal washings for cytology - Lymphadenectomy: pelvic and para-aortic New risk criteria for adjuvant treatment - FIGO stage (2009 system) - Grade - LVSI Statistical analysis : Kaplan-Meyer method, ROC curve

Results (1) Patients characteristics Characteristics N (%) or median (range) Characteristics N (%) or median (range) Median age, year 51 (29-81) Tumor grade Median parity 2 (0-6) 1 177 (67.8) FIGO stage 2 40 (15.3) IA 171 (65.5) 3 42 (16.1) IB 28 (10.7) N/A 2 (0.8) II 22 (8.4) Myometrial invasion IIIA 3 (1.1) < 1/2 involvement 192 (73.6) IIIB 2 (0.8) 1/2 involvement 69 (26.4) IIIC1 12 (4.6) LVSI IIIC2 16(6.1) Absent 197 (75.5) IVB 7 (2.7) Present 64 (24.5) Histology Adjuvant treatment Endometrioid 229 (87.7) No 178 (68.2) Serous papillary 13 (5.0) Yes 83 (31.8) Mixed 19 (7.3) FU, months 48 (10-122)

Results (2) Univariate and multivariate analyses Variable N(%) Univariate P value Multivariate OR (95% CI) P value Age (continuous) 261 0.07 0.99 (0.95-1.05) 0.91 Grade 1 177 - - - 2-3 82 <0.01 4.49 (1.59-12.67) 0.01 LVSI Absent 197 - - Present 64 <0.01 6.43 (1.97-21.06) <0.01 9

Results (3) Comparison of patients group GOG criteria (based on 1988 FIGO staging system) New Criteria (based on 2009 FIGO staging system) Low risk 78 (Stage IA) 170 (Stage IA) Intermediate risk 139 (Stage IB, IC, IIA, IIB) 46 (Stage IB, II) High-intermediate risk* 20 27 High risk 44 (Stage III, IV) 45 (Stage III, IV) * Risk factors 1) Grade 2 or 3 histology 2) Positive LVSI 3) Myometrial invasion to outer 1/3 1) Grade 2 or 3 histology 2) Positive LVSI Any age + 3 factors Age 50-69 + 2 factors Age 70 + 1 factor Any age + 1 factor 10

Results (4) Survival analysis Low risk High-Intermediate risk Low risk High-Intermediate risk High risk High risk A A Low risk High-Intermediate risk Low risk High-Intermediate risk High risk High risk B DFS (A) and OS (B) by GOG criteria (P < 0.01) DFS (A) and OS (B) by New criteria (P < 0.01) B 11

Results (5) Comparison of performances AUC (95% CI) SE P value GOG criteria 0.836 (0.740-0.931) 0.049 < 0.01 New Criteria 0.829 (0.732-0.926) 0.049 < 0.01 Pairwise comparison of ROC curves Difference between areas = 0.007 SE = 0.028 (95% CI, -0.048 to 0.061) P = 0.806 AUC (95% CI) SE P value GOG criteria 0.921 (0.883-0.958) 0.019 < 0.01 New Criteria 0.916 (0.877-0.956) 0.020 < 0.01 Pairwise comparison of ROC curves Difference between areas = 0.004 SE = 0.027 (95% CI, -0.049 to 0.057) P = 0.872 12

Conlusions The current study suggests the possibility that the simplified new criteria could be established, which predict prognosis and select proper candidates for adjuvant treatment in surgically staged endometrial cancer patients. Our new criteria may be easily applicable and offer useful information for planning strategy of adjuvant treatment in patients with endometrial cancer as the GOG criteria.