No Benefit to Routine Completion Lymphadenectomy for Sentinel Lymph Node Positive Melanoma

Transcription

1 No Benefit to Routine Completion Lymphadenectomy for Sentinel Lymph Node Positive Melanoma Michael Lowe, MD Assistant Professor of Surgery Winship Cancer Institute Emory University School of Medicine July 29,

2 Argument Against CLND Completion lymphadenectomy for sentinel lymph node positive melanoma has been the standard of care There is NO level I evidence to support it as such Two recent randomized clinical trials have shown that there is NO overall survival benefit to completion lymphadenectomy for sentinel lymph node positive melanoma Completion lymphadenectomy for sentinel lymph node positive melanoma should no longer be considered the standard of care 2

3 Background More is Better Courtesy of Donald L. Morton, MD 3

4 Background Kingham TP, et al. Ann Surg Onc. 2010;17(2):

5 DeCOG-SLT Recurrence-free Survival Leiter U, et al. Lancet Onc. 2016;17(6):

6 DeCOG-SLT: Overall Survival Leiter U, et al. Lancet Onc. 2016;17(6):

7 DeCOG-SLT Limitations Small study 473 patients included in the intention-to-treat analysis Observation: 233 patients CLND: 240 patients Head and neck melanomas not included Short follow up time Median follow up for 35.5 months in the observation group and 33.0 months in the CLND group 7

8 MSLT II Melanoma-specific Survival Faries MB, et al. N Engl J Med. 2017;376(23):

9 MSLT II 3-year melanoma-specific survival Observation: 86% CLND: 86% 3-year regional recurrence-free survival Observation: 77% CLND: 92% 3-year disease-free survival Observation: 63% CLND: 68% Faries MB, et al. N Engl J Med. 2017;376(23):

10 MSLT II 3-year regional recurrence-free survival Observation: 77% CLND: 92% Recurrence in the nodal basin as the ONLY site: Observation: 7.7% CLND: 1.3% An absolute difference of only 6.4% 10

11 Addressing DeCOG-SLT Shortcomings Larger study 1934 patients included in the intention-to-treat analysis Observation: 967 patients CLND: 967 patients Head and neck melanomas included Account for 13.7% of patients Longer follow up time Median follow up of 43 months ACOSOG Z0011: median follow up of 6.3 years without a difference in overall survival 11

12 MSLT II: Melanoma-Specific Survival The likelihood of seeing a statistically significant difference in MSS at any time in the future is statistically zero Faries MB, et al. N Engl J Med. 2017;376(23):

13 Arguments Against CLND Lack of survival benefit Complications Lymphedema In MSLT II, 24.1% of patients in the CLND had lymphedema compared to 6.3% in the observation group Wound complications Approximately 50% in inguinal lymphadenectomies 13

14 Arguments for CLND Prognostic value of knowing the status of the nonsentinel nodes Provides more accurate staging information Allows for risk stratification and selection for adjuvant therapy Regional control 70% reduction in regional recurrence with CLND Requirements for follow up Exam and ultrasound every 4 months for two years and every 6 months for years 3 to 5 14

15 Arguments for CLND: Rebuttal Prognostic value of knowing the status of the nonsentinel nodes Adjuvant regimens are toxic and provide only marginal improvement in survival Performing an invasive operation as a staging tool is counterproductive to the well being of patients Regional control Regional nodal recurrence is not equivalent to loss of regional nodal control 1 Requirements for follow up There is no evidence that ultrasound improves nodal recurrence detection; exam may suffice 1 Coit, D. N Engl J Med. 2017;376(23):

16 Management of the Sentinel Lymph Node is Crucial Morton DL, et al. N Engl J Med. 2014;370(7):

17 Management of the Sentinel Lymph Node is Crucial If MSLT I showed us that immediate CLND for patients with intermediate thickness melanoma and a positive SLN improved survival And MSLT II showed us that CLND is not beneficial for patient with positive SLN Then it s likely that SLNB is curative and that patients with nonsentinel metastases can undergo salvage CLND without adversely impacting survival 17

18 Until we find a way to determine who is going to have a positive sentinel lymph node before SLNB then all SLNB candidates should undergo SLNB, and only highly selected patients should undergo CLND for SLN positive disease 18