Total tumor burden as predictive tool of response and survival of patients with metastatic melanoma treated with nivolumab.

Abstract

e21022 Background: Nivolumab (NIVO) has shown increased results either in objective response rate (ORR), progression free survival (PFS) and overall survival (OS), which have completely changed the treatment of patients with metastatic melanoma (MM). Tools to guide selection of patients are absent Methods: This is a retrospective, observational, single-center study. The TBT was calculated considering the sum of the largest diameter of all measurable lesions and the smallest diameter of lymph nodes affected Results: 54 patients with histologiacally confirmed mm were included in the protocol (OCT/14-may/16). Patients had a median age of 61 years (22-86 years), 58% were male, and 73% of tumor were located in the skin. 42% had ECOG 1, 72% had M1c, and 36% had LDH over the upper limit of normality (ULN). 34% had the mutation of the BRAF (half of them treated with IBRAF). About 75% had no prior benefit with anti-CTLA4 and 21% of the population had brain metastases. The median follow-up was 11.1 months and the median NIVO doses was 10 cycles. The ORR was 30.2% and the clinical benefit rate was 54.7%. The median PFS was 6.89 months (95% CI 1.12 to 12.6 months) and OS was not reached. TBT being < or > the median impact on OS with HR 4.5 (95% CI 1.22 to 16.9; p = 0.024). Once again, there was a statistically significant difference in terms of PFS and OS when related to pooled TBT ≤ or > 200 mm. The PFSm was 9.4 months (95% CI NR) for TBT ≤ 200 and 2.6 months ( 95% CI 1.9 to 3.2 months) to TBT > 200, with a HR: 2.64 (95% CI 1.03 to 6.74; p = 0.042). OSm regarding TBT ≤ 200 was not reached and was 2.6 months (95% CI 2.0 to 3.2 months) to TBT > 200, with RH:8.9 (95% CI 2.56 to 30.9; p = 0.001). According to the Fisher's exact test analysis, there is a significant association between LDH > ULN and pooled TBT > 200, with p = 0.023. Also, a relation between grouped TBT ( ≤ 200 or > 200) and the type of response seemed to be significant, with p = 0.021. Conclusions: The results of our study are very consistent with current medical literature. In our study, high TBT was associated with less response rates and both less OS and PFS rates.

Lower tumor volume is associated with increased benefit from immune checkpoint inhibitors in patients with advanced non‐small‐cell lung cancer

“…The findings in this study are comparable to those of De Moares et al, who retrospectively analyzed the SOML of 54 patients with metastatic melanoma and demonstrated higher PFS for patients with a tumor burden < 200 mm 22 . Another recently published study examined the association between baseline tumor size and several clinical outcomes among patients with metastatic melanoma treated with pembrolizumab.…”

“…This finding is in contrast to several other studies demonstrating the prognostic potential of functional imaging in NSCLC, 21 and may be attributed to a small sample size. 22 Another recently published study examined the association between baseline tumor size and several clinical outcomes among patients with metastatic melanoma treated with pembrolizumab. In their study, Joseph et al showed that a baseline tumor size > 102 mm (the median tumor size in the cohort) was associated with lower response rates and worse prognosis.…”

Circulating tumor DNA analysis depicts subclonal architecture and genomic evolution of small cell lung cancer

“…Shedding of ctDNA is a complicated process affected by many factors and tumor burden is one of the most important determinants 24 . On the other hand, tumor burden is also a well-known prognostic factor associated with patient survival across different cancer types 28 – 31 . Therefore, it is not unreasonable to hypothesize that ctDNA levels may simply reflect tumor burden that in turn is associated with survival.…”