Session Item

Thursday
March 03
09:15 - 09:45
Gold Hall
The good and bad of TNM8
Pierre Blanchard, France;
Sjoukje Oosting, The Netherlands;
Wojciech Golusiński, Poland
0020
Keynote lecture
Months and severity Score(MOSES)- A new approach to summarize adverse events in oncological trials
Supriya Chopra, India
PD-0817

Abstract

Months and severity Score(MOSES)- A new approach to summarize adverse events in oncological trials
Authors:

Nilesh Ranjan1, Supriya Chopra2, Akshay Mangaj3, Sadhana Kannan4, Tapas Dora5, Reena Engineer1, Umesh Mahantshetty5, Lavanya Gurram1, Prachi Mittal6, Jaya Ghosh7, Amita Maheshwari8, TS Shylasree9, Sudeep Gupta10

1Tata Memorial Centre, Radiation oncology, Mumbai, India; 2ACTREC, Tata Memorial Centre, Radiation Oncology, Mumbai, India; 3MPCT hospital, Radiation oncology, Mumbai, India; 4ACTREC, Tata Memorial Centre, Epidemiology and Clinical Trials Unit, Mumbai, India; 5Homi Bhabha cancer hospital, Vizag, Radiation oncology, Vizag, India; 6Tata Memorial Centre, Radiation Oncology, Mumbai, India; 7Tata Memorial Centre, Medical oncology, Mumbai, India; 8Tata memorial Centre, Gynae surgical oncology, Mumbai, India; 9Tata Memorial Centre, Gynae surgical oncology, Mumbai, India; 10ACTREC, Tata Memorial Centre, Medical oncology, Mumbai, India

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Purpose or Objective

Toxicity reporting in oncology trials uses RTOG or CTCAE for adverse event reporting and captures only the maximum grade with no correlation with either temporal course or multiplicity of toxicity. We therefore propose a scoring method that takes severity and duration of toxicity into account (MOSES-Months and Severity Score) and compare it with conventional CTCAE maximum grade approach for accuracy in predicting symptomatic QOL using EORTC QLQ C30 and Cx24 considering patient reported outcomes as gold standard.

Material and Methods

For the purpose of the study, patients recruited into prospective phase 3 randomized trial of postoperative IMRT (NCT01279135) were included. CTCAE grade was available at a predetermined interval as per trial protocol along with QOL. A total of six different toxicities that had a corresponding QOL question item were included for evaluation (Diarrhea, abdominal pain, anorexia, urinary incontinence, urinary frequency and Fatigue). Time weighted scores i.e. MOSES was calculated for individual toxicities (CTCAE grade score x proportionate time of follow up) and cumulative MOSES across all toxicities was determined by summating individual toxicity MOSES for all six toxicities included in study. QOL data was categorized as either substantial symptomatic QOL (symptomatic QOL for 50 % or higher number of follow ups) or not. Symptomatic QOL is taken as any score of more than one given by patients to specific QOL questions. ROC analysis was performed to determine MOSES threshold that predicted for substantial symptomatic QOL. Categorizing CTCAE max grade as less than or ≥ grade 2 and categorizing MOSES above and below to the determined threshold, CTCAE and MOSES were tested for their accuracy in predicting substantial symptomatic QOL with p<0·05 was considered as statistically significant.

Results

A total of 201/300 symptomatic patients (either on CTCAE or QOL) were included for analysis. CTCAE maximum grade method demonstrated significant correlation with substantial symptomatic QOL for only diarrhea (p<0·0001) and abdominal pain (p=0·008) whereas MOSES correlated with Diarrhoea (p<0·001), abdominal pain (p<0·0001), urinary incontinence (p<0·01) and fatigue (p<0·001).On testing accuracy, MOSES predicted substantial symptomatic QOL equal or better than CTCAE across all symptoms[Table 1]. Cumulative MOSES including all the above toxicities was also calculated for each patient and was equal or better than CTCAE maximum grade method in predicting substantial symptomatic QOL across all functional scales [Table 2].


Table 1.Summary of correlation of “substantial symptomatic symptom specific QOL” with CTCAE Maximum grade and MOSES for different toxicities

Table 2.Accuracy of CTCAE and MOSES/C-MOSES in predicting substantial symptomatic symptom specific/Functional domains QOL 

Conclusion

Time imputed toxicity scoring correlates better with QOL symptom items and cumulative toxicity burden using MOSES provides good correlation with functional scales.