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903 Outcomes of well-differentiated papillary peritoneal mesothelioma
S140 901 ORAL Reporting adverse events (AEs) in cancer surgery randomized trial: A systemic analysis of published trials in oesogastric (OG) and gynecological (GY) cancer patients M. Leila1 , F. Narducci2 , C. Mariette3 , D. Alain4 , M. Vanseymortier5 , E. Leblanc2 , X. Paoletti6 , P. Collinet7 , S. Clisant5 , G. Piessen3 , N. Penel5 . 1 SIRIC OncoLille Consortium, EA2694 Epidemiology and Health Quality, Lille, France; 2 Centre Oscar Lambret, Gynecology Department, Lille, France; 3 Lille University Hospital, Department of Digestive and Oncological Surgery, Lille, France; 4 Lille University Hospital, Biostatisticand and Epidemiology Department, Lille, France; 5 Centre Oscar Lambret, Clinical Research Unit, Lille, France; 6 Institut Curie, Biostatistic Department, Paris, France; 7 Lille University Hospital, Gynecology Department, Lille, France Background: The accurate reporting of AEs is the perquisite for properly assessing the risk-benefit ratio of treatment. We hypothesized that this reporting could be improved. Materials and Methods: We systematically reviewed all consecutive fully published trials issued between 01/1990 and 11/2014, in English, including at least 50 patients and investigating surgery in OG or GY cancer patients. We have used an 18-items structured questionnaire based on the CONSORT statement. This questionnaire has been weighted using a 4-point Likert-scale by 15 experts (including 9 surgeons and 6 methodologists). We have first described the AE reporting, then applied the score calculated on the basis of expert survey and lastly analyzed the factors associated with the better score. Results: We have analyzed 179 published studies (133 OG and 46 GY). 68 studies assessed multimodal treatments (45.6%). Morbidity assessment was the primary objective of 56 studies (31.3%). Postoperative AEs were described in 161 studies (89.9%) and not described in 38 studies (21.2%). A clear and standardized definition of AEs was present in 27.2% of studies. In 16.8% of the studies, there was a grading system for reporting AEs (NCI-CTC AE, Dindo-Clavien scale, etc.). In only 8.3% of studies, AEs were reported by event and grade. Definition of expectedness, seriousness, causality and safety population were present in 0.0%, 0.0%, 7.8%, and 7.2%, respectively. Mean scores given by methodologists were significantly more stringent compared those given by surgeons (11.0 versus 6.0, p = 0.033). The most important discrepancy between both expert groups was “definition of safety population” regarded as very important for all methodologists and regarded as relatively not important in 5/7 surgeons (p = 0.001). We have then analyzed the factors associated with better score obtaining by studies. Score was not associated with period of publication, the continent of the sponsor, the impact factor of the journal publishing the study or the number of enrolled patients. Conclusion: AEs are poorly reported in surgery cancer trials. This reporting did not improve over time. This reporting is inaccurate even if the study is published in a high impact factor journal. No conflict of interest. 902 ORAL Robotic oncologic complexity score (ROCS) predicts major complications in computer-enhanced oncologic surgery − an internal and external validation O. Sgarbura1 , A. Coignac2 , V. Tomulescu3 , P. Rouanet4 , I. Popescu3 . 1 ´ Institut Regional du Cancer Montpellier, Oncologic surgery − CA2, ´ Montpellier, France; 2 Faculte´ de Medecine Montpellier, Chirurgie ´ viscerale, Montpellier, France; 3 Fundeni Clinical Instiute, General Surgery ´ and Liver Transplantation, Bucharest, Romania; 4 Institut Regional du Cancer Montpellier, Oncologic surgery − CA1, Montpellier, France Background: While there is little doubt that robotic interventions have already opened new horizons in surgery, due to its inherent complexity there is still an unmet need for tools allowing center-to-center performance comparisons and result prediction. The aim of this study is to validate a complexity score that could be a valuable instrument for further research. Material and Methods: The items of the Robotic Oncologic Complexity Score(ROCS) were based on risk factors identified in previous studies. We performed an internal validation on a 400 mixed oncologic cases cohort in a Romanian center and an external validation on a 348 mixed oncologic cases cohort in a French center. The primary endpoint was to assess the value of ROCS in predicting major complications. Results: The score was highly correlated with complications, major complications and hospital stay (p < 0.05). During the internal validation, a score over 4,25 had the best sensitivity (83%) and specificity (71%) on the ROC curve for predicting major complications with an AUC=0,72. During the external validation, a score over 5 had the best sensitivity (86%) and specificity (78%) for predicting major complications with an AUC=0,9.
Abstracts Conclusion: The robotic oncologic complexity score (ROCS) is a valuable tool in predicting major complications on mixed abdominal oncologic surgery cohorts operated with the robotic device. No conflict of interest. 903 ORAL Outcomes of well-differentiated papillary peritoneal mesothelioma G. Nash1 , M. Morris1 , L. Krug2 , M. Zauderer2 , V. Rusch1 , A. Cercek2 . 1 Memorial Sloan Kettering, Surgery, New York, USA; 2 Memorial Sloan Kettering, Medicine, New York, USA Background: Peritoneal mesothelioma is characterized by progression of disease in the peritoneum and limited long term survival. Well-differentiated papillary peritoneal mesothelioma (WDPPM) is a histologic subtype which may have a much more indolent course. Materials and Methods: Twenty-one patients from 1998 to 2014 with pathologically confirmed WDPPM, who were seen and followed at MSK, were identified from our retrospective database. Clinical records of patients were reviewed and noted for treatment methods and progression of disease (POD). This included 12 women and 9 men with a median age of 53 years (min-max, 16−74). One patient was excluded for presence of extraperitoneal disease (pleural) at diagnosis, leaving 20 patients for analysis. Results: Nine patients underwent cytoreductive surgery (CRS); 5 of whom were also treated with chemotherapy (initial chemotherapy was intraperitoneal in 4 and systemic in 1). Five CRS patients remain without evidence of disease (NED) by imaging with a median follow up of 3.1 years (0.6–16.9). Four CRS patients had POD after 1.3, 1.5, 3.0, and 3.1 years; one patient has died of disease (DOD) 2.7 years after POD and three remain alive with disease 1, 2.8, and 8.1 years after POD. Eleven patients were closely observed (OBS) (neither surgery, nor chemotherapy). Two OBS patients ultimately underwent CRS, one for progression after two years and one for an incidental pancreatic adenocarcinoma identified by imaging after one year; neither had gross residual disease after CRS. No OBS patient has received chemotherapy. Nine OBS remain NED by imaging with a median follow up of 2 years, (0−6.2). POD events in both groups were intraperitoneal. Conclusions: In our experience, WDPPM behaves very indolently with only one of twenty patients dying of disease (5.8 years after diagnosis). Patients selected for OBS are unlikely to progress within two years of diagnosis. In the absence of progressive disease, it appears appropriate to closely observe patients with WDPPM rather than select them for upfront aggressive treatment. No conflict of interest. 904 ORAL Radioembolisation for colorectal liver metastases after ablation: A prospective study − The RELAPSE study M. Samim1 , W. Prevoo2 , M. Van den Bosch3 , I. Borel Rinkes1 , T. Ruers4 , H. Verkooijen3 , M. Lam3 , C. Van Kessel1 , R. Van Hillegersberg1 . 1 UMC Utrecht, Surgery, Utrecht, Netherlands; 2 Dutch Cancer Institute, Antoni van Leeuwenhoek Hosputal, Interventional Radiology, Amsterdam, Netherlands; 3 UMC Utrecht, Radiology, Utrecht, Netherlands; 4 Dutch Cancer Institute, Antoni van Leeuwenhoek Hosputal, Surgery, Amsterdam, Netherlands Background: Local tumour recurrence after thermal ablation therapy is a frequent phenomenon, which jeopardizes progression free survival of patients with unresectable colorectal liver metastases (CRLM). Experimental data demonstrated a stimulating effect of ablation on the outgrowth of remaining tumour cells surrounding the lesion leading to local tumour recurrence. Selective internal yttrium-90 radioembolisation (90 Y RE) is a form of brachytherapy in which radioactive microspheres are injected into the hepatic artery. Currently, 90 Y RE is used in salvage setting in patients with unresectable CRLM. Combining thermal ablation and 90 Y RE has the potential to reduce the risk of local liver recurrence and prolong time to tumour progression in patients with CRLM. The aim of this study is to investigate the efficacy of post-ablative 90 Y RE in patients with CLRM for the reduction of the local tumour recurrence rate. Design: A multicentre, IDEAL stage 2b prospective observational study. Population: Adults 18 years of age with CRLM, previously treated with potentially curative surgery of the primary tumour (R0), planned for curative thermal ablation of liver metastases are eligible. Patients undergoing thermal ablation therapy combined with surgical resection of the liver are excluded from this study. We aim to enrol 50 patients in the study. For safety reasons, and to prevent unnecessary exposure of patients to harmful effects of the combine therapy, stopping rules have been defined.
Abstracts Conclusion: The robotic oncologic complexity score (ROCS) is a valuable tool in predicting major complications on mixed abdominal oncologic surgery cohorts operated with the robotic device. No conflict of interest. 903 ORAL Outcomes of well-differentiated papillary peritoneal mesothelioma G. Nash1 , M. Morris1 , L. Krug2 , M. Zauderer2 , V. Rusch1 , A. Cercek2 . 1 Memorial Sloan Kettering, Surgery, New York, USA; 2 Memorial Sloan Kettering, Medicine, New York, USA Background: Peritoneal mesothelioma is characterized by progression of disease in the peritoneum and limited long term survival. Well-differentiated papillary peritoneal mesothelioma (WDPPM) is a histologic subtype which may have a much more indolent course. Materials and Methods: Twenty-one patients from 1998 to 2014 with pathologically confirmed WDPPM, who were seen and followed at MSK, were identified from our retrospective database. Clinical records of patients were reviewed and noted for treatment methods and progression of disease (POD). This included 12 women and 9 men with a median age of 53 years (min-max, 16−74). One patient was excluded for presence of extraperitoneal disease (pleural) at diagnosis, leaving 20 patients for analysis. Results: Nine patients underwent cytoreductive surgery (CRS); 5 of whom were also treated with chemotherapy (initial chemotherapy was intraperitoneal in 4 and systemic in 1). Five CRS patients remain without evidence of disease (NED) by imaging with a median follow up of 3.1 years (0.6–16.9). Four CRS patients had POD after 1.3, 1.5, 3.0, and 3.1 years; one patient has died of disease (DOD) 2.7 years after POD and three remain alive with disease 1, 2.8, and 8.1 years after POD. Eleven patients were closely observed (OBS) (neither surgery, nor chemotherapy). Two OBS patients ultimately underwent CRS, one for progression after two years and one for an incidental pancreatic adenocarcinoma identified by imaging after one year; neither had gross residual disease after CRS. No OBS patient has received chemotherapy. Nine OBS remain NED by imaging with a median follow up of 2 years, (0−6.2). POD events in both groups were intraperitoneal. Conclusions: In our experience, WDPPM behaves very indolently with only one of twenty patients dying of disease (5.8 years after diagnosis). Patients selected for OBS are unlikely to progress within two years of diagnosis. In the absence of progressive disease, it appears appropriate to closely observe patients with WDPPM rather than select them for upfront aggressive treatment. No conflict of interest. 904 ORAL Radioembolisation for colorectal liver metastases after ablation: A prospective study − The RELAPSE study M. Samim1 , W. Prevoo2 , M. Van den Bosch3 , I. Borel Rinkes1 , T. Ruers4 , H. Verkooijen3 , M. Lam3 , C. Van Kessel1 , R. Van Hillegersberg1 . 1 UMC Utrecht, Surgery, Utrecht, Netherlands; 2 Dutch Cancer Institute, Antoni van Leeuwenhoek Hosputal, Interventional Radiology, Amsterdam, Netherlands; 3 UMC Utrecht, Radiology, Utrecht, Netherlands; 4 Dutch Cancer Institute, Antoni van Leeuwenhoek Hosputal, Surgery, Amsterdam, Netherlands Background: Local tumour recurrence after thermal ablation therapy is a frequent phenomenon, which jeopardizes progression free survival of patients with unresectable colorectal liver metastases (CRLM). Experimental data demonstrated a stimulating effect of ablation on the outgrowth of remaining tumour cells surrounding the lesion leading to local tumour recurrence. Selective internal yttrium-90 radioembolisation (90 Y RE) is a form of brachytherapy in which radioactive microspheres are injected into the hepatic artery. Currently, 90 Y RE is used in salvage setting in patients with unresectable CRLM. Combining thermal ablation and 90 Y RE has the potential to reduce the risk of local liver recurrence and prolong time to tumour progression in patients with CRLM. The aim of this study is to investigate the efficacy of post-ablative 90 Y RE in patients with CLRM for the reduction of the local tumour recurrence rate. Design: A multicentre, IDEAL stage 2b prospective observational study. Population: Adults 18 years of age with CRLM, previously treated with potentially curative surgery of the primary tumour (R0), planned for curative thermal ablation of liver metastases are eligible. Patients undergoing thermal ablation therapy combined with surgical resection of the liver are excluded from this study. We aim to enrol 50 patients in the study. For safety reasons, and to prevent unnecessary exposure of patients to harmful effects of the combine therapy, stopping rules have been defined.