Patterns of Care and Prognosis of Retroperitoneal Sarcomas in the Primary and Advanced Settings A Large Multicentric Retrospective Analysis from the French.

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Patterns of Care and Prognosis of Retroperitoneal Sarcomas in the Primary and Advanced Settings A Large Multicentric Retrospective Analysis from the French Sarcoma Group M. Toulmonde, E Stoeckle, S. Bonvalot, N. Isambert, E Bompas, N. Penel, V. Brouste, J-Y. Blay, S. Piperno-Neumann, C. Chevreau, P. Terrier, D. Ranchère-Vince, J-M. Coindre, B. Nguyen Bui, A. Italiano

Retroperitoneal Sarcomas (RPS) Rare and heterogeneous Poor prognosis Heterogeneous data Controversies -Type of surgery -Role of radiotherapy Diversity of presentations in advanced setting

Objectives  Description of patterns of care  Prognostic factors  Subgroup analyses according to histological subtypes I) On a Large homogeneous cohort of patients with completely resected primary RPS II) In the advanced setting

Patients and Methods Prospective database of the French Sarcoma Group Retrospective review of medical charts Patients ≥ 18 years with primary RPS Diagnosis between 01/01/1988 and 31/12/2008 Referred to one of 12 participating French Comprehensive Cancer Centers Systematic histological review by an expert pathologist member of the GSF-GETO Statistical analyses according to standard methods (Log- rank, Cox model)

Results 586 patients Median follow-up = 6.5 years [ ] 26 patients not operated 19 patients initial abdominal sarcomatosis 30 patients initial distant metastasis 586 patients 537 patients M0 511 patients operated 110 patients R2 12 patients unknown resection status 389 patients R0/R1

Characteristics at diagnosis Patients (n=586) % Median age 57 years (18- 89) Sex ratio M/F 0.87 Median tumor size 17 cm (4-85) Histology DDLPS WDLPS LMS US Other % 23% 18.5% 7% 10% Grade NS % 41.5% 30.5% 2% Multifocality9516% LR involvement24842% Vascular involvement 6010% DDLPS: Dedifferentiated Liposarcoma WDLPS: Well-Differentiated Liposarcomas LMS: Leiomyosarcomas US: Unclassified Sarcomas Other: Other subtypes LR: Locoregional

Patients (n=511) % Type of surgery Simple Large Compartmental NS % 39% 24% - Expert surgeon % Complete resection38976% Tumor rupture8015.5% ≥1 resected organ33265% Perioperative RT14629% Perioperative CT8917% Initial treatment modalities Patients (n=586) % Preoperative biopsy 23440% Pretherapeutic multidisciplinary assessment 16528%

Evolution (389 patients R0/R1) 5-year LR relapse-free Survival = 46% [41-52] Time (years) Number at risk 95% CI LR relapse-free Survival Probability

Evolution (389 patients R0/R1) Time (years) Number at risk 95% CI Overall Survival Probability Overall Survival 5-year overall survival = 66% [61-71]

Predictive factors for complete surgery (511 patients operated ) Multivariate analysis OR[I95%CI] (p) Histology (WDLPS) DDLPS LMS US Other [ [ ] [ ] [ ] (p= 0.02) (p= 0.03) (p= 0.5) (p= 0.05) GradeNot significant Multifocality3 [ ] (p= 0.005) LR involvement14.1 [ ] (p<0.001) Type of surgery (simple) Compartmental Large [ ] [ ] (p<0.001) Expert Surgeon0.3 [ ] (p=0.001)

Prognostic factors for LR relapse Multivariate analysis HR[95%CI](p) Male sex1.5 [1.1-2] (p=0.006) Histology Not significant Grade Not significant LR involvement1.6 [ ] (p=0.004) Type of surgery Not significant Expert Surgeon0.5 [ ] (p<0.001) Tumor rupture2.9 [ ] (p<0.001) Perioperative RT0.5 [ ] (p<0.001) Time (years) LR relapse-free survival according to surgeon’s expertise No expert surgeon Expert surgeon Time (years) LR relapse-free survival according to perioperative radiotherapy No perioperative radiotherapy Perioperative radiotherapy

Prognostic factors for abdominal sarcomatosis Multivariate analysis HR[95%CI] (p) Grade (1) [ ] [ ] (p=0.4) (p= 0.05) LR involvement1.8 [ ] (p=0.04) Expert surgeon0.5 [ ] (p=0.02) Tumor rupture4.2 [ ] (p<0.001) Sarcomatosis-free survival according to tumor rupture Tumor rupture No tumor rupture Time (years)

Prognostic factors for distant metastasis Multivariate analysis HR[95%CI] (p) Tumor size < 18 cmNot significant Histology (WDLPS) DDLPS LMS US Other [ ] [ ] [ ] [ ] (p=0.027) (p<0.001) (p=0.1) (p<0.001) GradeNot significant LR involvement1.6 [1-2.5] (p=0.034) Vascular involvement Not significant Perioperative RTNot significant Time (years) DDLPS WDLPS LMS US Others Distant metastasis-free survival according to histology

Prognostic factors for overall survival Multivariate analysis HR[95%CI] (p) Age ≥ 56 years1.4 [1-1.9] (p=0.04) Male sex1.7 [ ] (p<0.001) HistologyNot significant Grade (1) [ ] [ ] (p=0.001) (p<0.001) LR involvement1.6 [ ] (p=0.002) Tumor rupture2 [1.3-3] (p=0.002) Time (years) Overall survival according to tumor rupture Tumor rupture No tumor rupture Time ( years ) grade 1 grade 3 grade 2 Overall survival according to grade

Sub-group analysis according to histology for LR relapse Multivariate analysis HR[95%CI] (p) WDLPS Tumor size ≥ 18 cm 2.6 [1.2-6] (p=0.02) Tumor rupture4 [ ] (p=0.002) DDLPS Expert surgeon0.6 [ ](p=0.01) Perioperative RT0.6 [ ](p=0.028) LMS Tumor rupture10.1 [ ](p<0.001)

Sub-group analysis according to histology for OS Multivariate analysis HR[95%CI] (p) WDLPS Age ≥ 56 years3.3 [ ] (p=0.004) Multifocality3.1 [ ] (p=0.02) LR involvement2.3 [ ] (p=0.05) DDLPS Male sex1.8 [ ](p=0.014) Grade 31.8 [ ](p=0.015) Tumor rupture2.3 [ ](p=0.008) LMS LR involvement2.4 [ ](p=0.035) Type of surgery Simple Compartmental [ ] [ ] (p=0.2) (p=0.018)

Patterns of care in advanced stage 299 patients palliative CT for advanced disease 586 patients 50 patients palliative surgery First line palliative CT - Monotherapy = 49% -Anthracycline-based = 75% Median number of line = 2 (1-8) -33% received ≥ 3 lines

OS from first line of palliative CT Median Overall Survival All 15.8 months[13-18] WDLPS26.8 months[12-65] LMS19.6 months [16-25] US14.4 months[6-19] DDLPS13.5 months [11-17] Other11.8 months[5-16] Time (years) Number at risk 95% CI Overall survival Overall Survival

OS from first line of palliative CT Median Overall Survival All 15.8 months[13-18] WDLPS26.8 months[12-65] LMS19.6 months [16-25] US14.4 months[6-19] DDLPS13.5 months [11-17] Other11.8 months[5-16] DDLPS WDLPS LMS US Other Time (years) Overall survival according to histology

Prognostic Factors for overall survival from first line of palliative CT Multivariate analysis HR[95%CI] (p) Male sex1.5[ ] (p=0.009) PS (0) 1 ≥ [ ] [ ] (p=0.001) (p<0.001) Grade (1) [ ] [ ] (p=0.02) (p<0.001) Histology Not significant Time (years) Overall survival according to grade grade 1 grade 3 grade Time (years) PS = 0 PS =1 PS ≥ 2 Overall survival according to PS Stage of the disease Palliative surgery no difference

Discussion Predominance of DDLPS Poor conformity to practice guidelines Surgical expertise is a major prognostic factor DDLPS  WDLPS  LR involvement and OS LMS  limits of surgery on OS Need for histology-specific clinical trials - Radiotherapy and LR relapse - Grade and OS

Acknowledgements V. Brouste J-B. Courrèges E. Stoeckle G. Kantor A. Neuville J-M. Coindre B. Nguyen Bui A. Italiano O. Riou N. Isambert E Bompas N. Penel C. Delcambre-Lair F. Duee E. Saada M. Jean-Denis P. Terrier D. Ranchère-Vince A. Lecesne S. Bonvalot J-Y. Blay S. Piperno-Neumann C. Chevreau J-O. Bay A. Thyss

Survivals according to histology LR relapse-free survival [95%CI] Distant metastasis-free survival [95% CI] overall survival [95%CI] At 5 yearsAt 10 yearsAt 5 yearsAt 10 yearsAt 5 yearsAt 10 years WDLPS53% [42-63]21% [10-35]96% [90-99]94% [87-98]92% [84-96]63% [47-75] DDLPS40% [32-49]24% [14-36]86% [79-91]81% [70-88]61% [52-68]31% [21-42] LMS55% [42-67] 47% [34-59]28% [14-43]61% [49-72]30% [16-44] US25% [9-46]-73% [34-91]-35% [14-57]- Other48% [28-66] 63% [43-78]55% [32-74]43% [26-59]31% [14-50]

Sub-group analysis according to histology for overall survival after first line palliative CT Multivariate analysis HR[95%CI] (p) DDLPS PS (0) 1 ≥ [1-2.5] [ ] (p=0.04) (p=0.01) Grade (1*and 2) 31.7[ ] (p=0.03) LMS PSNot significant Grade (1) [ ] [ ] (p=0.037) (p=0.005) Stage (LR) Sarcomatosis Distant metastasis [0.3-2] [ ] (p=0.59) (p=0.003)

Time (years) Number at risk 95% CI LR-free Survival LR relapse- free Survival (Probability)

grade_pal = grade_pal = grade_pal = 1 Number at risk grade_pal = 1grade_pal = 2 grade_pal = Time (years) Overall Survival according to grade grade 1 grade 3 grade 2

ps_pal_recup_2c = 2 ou ps_pal_recup_2c = ps_pal_recup_2c = Number at risk Time (years) PS = 0 PS =1 PS ≥ 2 Overall Survival according to PS

Sub-group analysis according to histology WDLPS LR Relapse HR[95%CI] (p) Tumor size ≥ 18 cm 2.6[1.2-6] (p=0.02) Expert surgeonNot significant Tumor rupture4[ ] (p=0.002) Perioperative RTNot significant Overall survival Age ≥ 56 years3.3[ ] (p=0.004) Multifocality3.1[ ] (p=0.02) LR involvement2.3[ ] (p=0.05) DDLPS LR RelapseHR[95%CI](p) Expert surgeon0.6[ ](p=0.01) Perioperative RT0.6[ ](p=0.028) Overall survival Age ≥ 56 yearsNot significant Male sex1.8[ ](p=0.014) Grade 31.8[ ](p=0.015) Tumor rupture2.3[ ](p=0.008) LMS LR RelapseHR[95%CI](p) Tumor rupture10.1[ ](p<0.001) Overall survival LR involvement2.4[ ](p=0.035) Type of surgery (large) Simple Compartmental [ ] [ ] (p=0.2) (p=0.018)