Benefit Confirmed for Sentinel Node Biopsy vs Observation in Melanoma
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Benefit Confirmed for Sentinel Node Biopsy vs Observation in Melanoma

› Forums › Cutaneous Melanoma Community › Benefit Confirmed for Sentinel Node Biopsy vs Observation in Melanoma

  • Post
    • February 14, 2014 at 5:42 pm
    BrianP
    Participant
       

      TAKE-HOME MESSAGE

       

      • This long-term follow-up analysis of a phase III study confirmed the benefit of sentinel lymph node biopsy vs observation in patients with cutaneous melanoma. The 10-year disease-free survival (DFS) rates for patients with intermediate-thickness and thick melanomas were 71.3% vs 64.7% and 50.7% vs 40.5%, respectively. In addition, 10-year distant DFS and 10-year melanoma-specific survival were significantly better in the biopsy vs the observation group (HR, 0.62; and HR, 0.56).
      • Sentinel lymph node biopsy provided accurate information on staging, improved regional disease control, and prolonged melanoma-specific survival.

       

      ABSTRACT

       

      Background

      Sentinel-node biopsy, a minimally invasive procedure for regional melanoma staging, was evaluated in a phase 3 trial.

      Methods

      We evaluated outcomes in 2001 patients with primary cutaneous melanomas randomly assigned to undergo wide excision and nodal observation, with lymphadenectomy for nodal relapse (observation group), or wide excision and sentinel-node biopsy, with immediate lymphadenectomy for nodal metastases detected on biopsy (biopsy group).

      Results

      No significant treatment-related difference in the 10-year melanoma-specific survival rate was seen in the overall study population (20.8% with and 79.2% without nodal metastases). Mean (±SE) 10-year disease-free survival rates were significantly improved in the biopsy group, as compared with the observation group, among patients with intermediate-thickness melanomas, defined as 1.20 to 3.50 mm (71.3±1.8% vs. 64.7±2.3%; hazard ratio for recurrence or metastasis, 0.76; P = 0.01), and those with thick melanomas, defined as >3.50 mm (50.7±4.0% vs. 40.5±4.7%; hazard ratio, 0.70; P = 0.03). Among patients with intermediate-thickness melanomas, the 10-year melanoma-specific survival rate was 62.1±4.8% among those with metastasis versus 85.1±1.5% for those without metastasis (hazard ratio for death from melanoma, 3.09; P<0.001); among patients with thick melanomas, the respective rates were 48.0±7.0% and 64.6±4.9% (hazard ratio, 1.75; P = 0.03). Biopsy-based management improved the 10-year rate of distant disease–free survival (hazard ratio for distant metastasis, 0.62; P = 0.02) and the 10-year rate of melanoma-specific survival (hazard ratio for death from melanoma, 0.56; P = 0.006) for patients with intermediate-thickness melanomas and nodal metastases. Accelerated-failure-time latent-subgroup analysis was performed to account for the fact that nodal status was initially known only in the biopsy group, and a significant treatment benefit persisted.

      Conclusions

      Biopsy-based staging of intermediate-thickness or thick primary melanomas provides important prognostic information and identifies patients with nodal metastases who may benefit from immediate complete lymphadenectomy. Biopsy-based management prolongs disease-free survival for all patients and prolongs distant disease–free survival and melanoma-specific survival for patients with nodal metastases from intermediate-thickness melanomas.

       

      The New England Journal of Medicine

      Final Trial Report of Sentinel-Node Biopsy Versus Nodal Observation in Melanoma

      N. Engl. J. Med 2014 Feb 13;370(7)599-609, DL Morton, JF Thompson, AJ Cochran, N Mozzillo, OE Nieweg, DF Roses, HJ Hoekstra, CP Karakousis, CA Puleo, BJ Coventry, M Kashani-Sabet, BM Smithers, E Paul, WG Kraybill, JG McKinnon, H-J Wang, R Elashoff, MB Faries

       

    Viewing 8 reply threads
    • Replies
        • February 15, 2014 at 2:11 pm
        POW
        Participant

          Thanks for posting this, Brian. However, I'm afraid that the horse has been out of the barn for a long time on this one. This sentinel lymph node study (named MSLT-I) was started in 1994 and several interim reports have been published. They long ago proved the benefit of doing SNL on primary melanomas > 1.3 mm deep or on "high risk" melanomas < 1.3 mm deep. That is now standard practice, thank heavens.

          The more important question now is whether or not to do a complete lymph node dissection (CLND) when positive nodes are found via SLNB. That question is being addressed by another study called MSLT-II which began in 2004 and is currently recruiting patients. Preliminary results indicate that only 12% of patients who undergo CLND have positive nodes. This trial is to determine whether removing those nodes actually improves the long-term outcome for these patients. 

          In poking around the Internet about this topic (yeah, I'm a science geek) I found one very interesting fact. ( See "Multicenter Selective Lymphadenectomy Trial II (MSLTII)" from the Melanoma Institute Australia North Sydney). 

          In this report, the authors say that 20% of SLNB lymph nodes that were judged to be melanoma negative by standard pathology were subsequently found to be melanoma positive by a more sensitive technique called RT-PCR. 

          There is no evidence that this tiny number of melanoma cells, left undetected, will actually result in disease progression. I assume that is one of the questions MSLT-II is trying to answer. However, if I had a high-risk primary melanoma (> 1.0 mm or ulcerated or mitotic index >1.0), I would ask that my SLNB sample be sent for RT-PCR in addition to standard pathology. I would just want to know. 

           

          • February 15, 2014 at 2:11 pm
          POW
          Participant

            Thanks for posting this, Brian. However, I'm afraid that the horse has been out of the barn for a long time on this one. This sentinel lymph node study (named MSLT-I) was started in 1994 and several interim reports have been published. They long ago proved the benefit of doing SNL on primary melanomas > 1.3 mm deep or on "high risk" melanomas < 1.3 mm deep. That is now standard practice, thank heavens.

            The more important question now is whether or not to do a complete lymph node dissection (CLND) when positive nodes are found via SLNB. That question is being addressed by another study called MSLT-II which began in 2004 and is currently recruiting patients. Preliminary results indicate that only 12% of patients who undergo CLND have positive nodes. This trial is to determine whether removing those nodes actually improves the long-term outcome for these patients. 

            In poking around the Internet about this topic (yeah, I'm a science geek) I found one very interesting fact. ( See "Multicenter Selective Lymphadenectomy Trial II (MSLTII)" from the Melanoma Institute Australia North Sydney). 

            In this report, the authors say that 20% of SLNB lymph nodes that were judged to be melanoma negative by standard pathology were subsequently found to be melanoma positive by a more sensitive technique called RT-PCR. 

            There is no evidence that this tiny number of melanoma cells, left undetected, will actually result in disease progression. I assume that is one of the questions MSLT-II is trying to answer. However, if I had a high-risk primary melanoma (> 1.0 mm or ulcerated or mitotic index >1.0), I would ask that my SLNB sample be sent for RT-PCR in addition to standard pathology. I would just want to know. 

             

            • February 15, 2014 at 2:11 pm
            POW
            Participant

              Thanks for posting this, Brian. However, I'm afraid that the horse has been out of the barn for a long time on this one. This sentinel lymph node study (named MSLT-I) was started in 1994 and several interim reports have been published. They long ago proved the benefit of doing SNL on primary melanomas > 1.3 mm deep or on "high risk" melanomas < 1.3 mm deep. That is now standard practice, thank heavens.

              The more important question now is whether or not to do a complete lymph node dissection (CLND) when positive nodes are found via SLNB. That question is being addressed by another study called MSLT-II which began in 2004 and is currently recruiting patients. Preliminary results indicate that only 12% of patients who undergo CLND have positive nodes. This trial is to determine whether removing those nodes actually improves the long-term outcome for these patients. 

              In poking around the Internet about this topic (yeah, I'm a science geek) I found one very interesting fact. ( See "Multicenter Selective Lymphadenectomy Trial II (MSLTII)" from the Melanoma Institute Australia North Sydney). 

              In this report, the authors say that 20% of SLNB lymph nodes that were judged to be melanoma negative by standard pathology were subsequently found to be melanoma positive by a more sensitive technique called RT-PCR. 

              There is no evidence that this tiny number of melanoma cells, left undetected, will actually result in disease progression. I assume that is one of the questions MSLT-II is trying to answer. However, if I had a high-risk primary melanoma (> 1.0 mm or ulcerated or mitotic index >1.0), I would ask that my SLNB sample be sent for RT-PCR in addition to standard pathology. I would just want to know. 

               

              • February 15, 2014 at 3:22 pm
              Bubbles
              Participant

                Brian,

                Thanks so much for posting this study.  Having experienced this process, TWICE, it is interesting to find new data coming out about it.  I just posted a report of it with some interesting comments by Balch (one of the biggest dogs in surgical oncology, from University of TX, Dallas) and Faries (Director of melanoma research at the John Wayne Cancer Institute, CA) on my blog.  If study results can impress these guys, then it sure impresses me!  Apart from that, because COMPLETE lymphadenectomy was utilized in every patient in the study group who had a positve sentinel node, this study goes further in answering the quesiton of whether removal of the entire nodal basin is better than simple sentinel node removal alone.  It tells us that complete lymphadenectomy in patients with a positive sentinel node, is therapeutic.

                Thanks, Celeste

                  • February 15, 2014 at 4:37 pm
                  Brent Morris
                  Participant

                    This data is important because it represents the final 10 year set. It is in the context of a larger controversy in the surgical management of melanoma. (http://www.ascopost.com/issues/may-1,-2013/does-every-melanoma-patient-with-a-positive-sentinel-node-need-more-lymph-nodes-removed.aspx). A bigger question is when the new treatments available will be used as adjuvant therapy ( for instance the Braf/Mek combo or the immune checkpoint drugs) to skip using the surgical approach at all. Then we will see the need for surgery to control Stage 3 melanoma dissappear. Hopefully this will happen sooner rather than later, but always agonizingly slowly.

                    • February 15, 2014 at 5:35 pm
                    POW
                    Participant

                      Thanks for the link to the ASCO Post, Brent. I read a couple of the articles and found them very interesting. 

                      The most interesting thing I read was the interviews with surgeons who oppose doing complete lymph node dissections ever. The main reason for their opposition is that even if they find positive nodes during a CLND, what difference does it make to the patient? The patient is still considered Stage III (as they were after a positive SLNB) and there are no effective treatments they can offer to Stage III patients. To this day, the only FDA approved treatment for Stage III is interferon.

                      This seems to be echoing what you are saying– we need to find some way to get the Stage IV treatments made available to Stage III patients so that they do NOT become Stage IV. Absolutely!

                      • February 15, 2014 at 8:03 pm
                      Brent Morris
                      Participant

                        Actually the study does indicate that biopsy with CLND to follow indeed makes a positive difference for the patients in Stage 3. Mean (±SE) 10-year disease-free survival rates were significantly improved in the biopsy group, as compared with the observation group, among patients with intermediate-thickness melanomas, defined as 1.20 to 3.50 mm (71.3±1.8% vs. 64.7±2.3%; hazard ratio for recurrence or metastasis, 0.76; P = 0.01), and those with thick melanomas, defined as >3.50 mm (50.7±4.0% vs. 40.5±4.7%; hazard ratio, 0.70; P = 0.03).It does not of course change their stage.Their sentinal node and all other nodes were removed. Still waiting to be defined is the benefit of simple positive sentinel node removal by itself and the significance of minimal sentinal node tumor burden.

                        • February 15, 2014 at 8:03 pm
                        Brent Morris
                        Participant

                          Actually the study does indicate that biopsy with CLND to follow indeed makes a positive difference for the patients in Stage 3. Mean (±SE) 10-year disease-free survival rates were significantly improved in the biopsy group, as compared with the observation group, among patients with intermediate-thickness melanomas, defined as 1.20 to 3.50 mm (71.3±1.8% vs. 64.7±2.3%; hazard ratio for recurrence or metastasis, 0.76; P = 0.01), and those with thick melanomas, defined as >3.50 mm (50.7±4.0% vs. 40.5±4.7%; hazard ratio, 0.70; P = 0.03).It does not of course change their stage.Their sentinal node and all other nodes were removed. Still waiting to be defined is the benefit of simple positive sentinel node removal by itself and the significance of minimal sentinal node tumor burden.

                          • February 15, 2014 at 8:03 pm
                          Brent Morris
                          Participant

                            Actually the study does indicate that biopsy with CLND to follow indeed makes a positive difference for the patients in Stage 3. Mean (±SE) 10-year disease-free survival rates were significantly improved in the biopsy group, as compared with the observation group, among patients with intermediate-thickness melanomas, defined as 1.20 to 3.50 mm (71.3±1.8% vs. 64.7±2.3%; hazard ratio for recurrence or metastasis, 0.76; P = 0.01), and those with thick melanomas, defined as >3.50 mm (50.7±4.0% vs. 40.5±4.7%; hazard ratio, 0.70; P = 0.03).It does not of course change their stage.Their sentinal node and all other nodes were removed. Still waiting to be defined is the benefit of simple positive sentinel node removal by itself and the significance of minimal sentinal node tumor burden.

                            • February 15, 2014 at 5:35 pm
                            POW
                            Participant

                              Thanks for the link to the ASCO Post, Brent. I read a couple of the articles and found them very interesting. 

                              The most interesting thing I read was the interviews with surgeons who oppose doing complete lymph node dissections ever. The main reason for their opposition is that even if they find positive nodes during a CLND, what difference does it make to the patient? The patient is still considered Stage III (as they were after a positive SLNB) and there are no effective treatments they can offer to Stage III patients. To this day, the only FDA approved treatment for Stage III is interferon.

                              This seems to be echoing what you are saying– we need to find some way to get the Stage IV treatments made available to Stage III patients so that they do NOT become Stage IV. Absolutely!

                              • February 15, 2014 at 5:35 pm
                              POW
                              Participant

                                Thanks for the link to the ASCO Post, Brent. I read a couple of the articles and found them very interesting. 

                                The most interesting thing I read was the interviews with surgeons who oppose doing complete lymph node dissections ever. The main reason for their opposition is that even if they find positive nodes during a CLND, what difference does it make to the patient? The patient is still considered Stage III (as they were after a positive SLNB) and there are no effective treatments they can offer to Stage III patients. To this day, the only FDA approved treatment for Stage III is interferon.

                                This seems to be echoing what you are saying– we need to find some way to get the Stage IV treatments made available to Stage III patients so that they do NOT become Stage IV. Absolutely!

                                • February 15, 2014 at 4:37 pm
                                Brent Morris
                                Participant

                                  This data is important because it represents the final 10 year set. It is in the context of a larger controversy in the surgical management of melanoma. (http://www.ascopost.com/issues/may-1,-2013/does-every-melanoma-patient-with-a-positive-sentinel-node-need-more-lymph-nodes-removed.aspx). A bigger question is when the new treatments available will be used as adjuvant therapy ( for instance the Braf/Mek combo or the immune checkpoint drugs) to skip using the surgical approach at all. Then we will see the need for surgery to control Stage 3 melanoma dissappear. Hopefully this will happen sooner rather than later, but always agonizingly slowly.

                                  • February 15, 2014 at 4:37 pm
                                  Brent Morris
                                  Participant

                                    This data is important because it represents the final 10 year set. It is in the context of a larger controversy in the surgical management of melanoma. (http://www.ascopost.com/issues/may-1,-2013/does-every-melanoma-patient-with-a-positive-sentinel-node-need-more-lymph-nodes-removed.aspx). A bigger question is when the new treatments available will be used as adjuvant therapy ( for instance the Braf/Mek combo or the immune checkpoint drugs) to skip using the surgical approach at all. Then we will see the need for surgery to control Stage 3 melanoma dissappear. Hopefully this will happen sooner rather than later, but always agonizingly slowly.

                                  • February 15, 2014 at 3:22 pm
                                  Bubbles
                                  Participant

                                    Brian,

                                    Thanks so much for posting this study.  Having experienced this process, TWICE, it is interesting to find new data coming out about it.  I just posted a report of it with some interesting comments by Balch (one of the biggest dogs in surgical oncology, from University of TX, Dallas) and Faries (Director of melanoma research at the John Wayne Cancer Institute, CA) on my blog.  If study results can impress these guys, then it sure impresses me!  Apart from that, because COMPLETE lymphadenectomy was utilized in every patient in the study group who had a positve sentinel node, this study goes further in answering the quesiton of whether removal of the entire nodal basin is better than simple sentinel node removal alone.  It tells us that complete lymphadenectomy in patients with a positive sentinel node, is therapeutic.

                                    Thanks, Celeste

                                    • February 15, 2014 at 3:22 pm
                                    Bubbles
                                    Participant

                                      Brian,

                                      Thanks so much for posting this study.  Having experienced this process, TWICE, it is interesting to find new data coming out about it.  I just posted a report of it with some interesting comments by Balch (one of the biggest dogs in surgical oncology, from University of TX, Dallas) and Faries (Director of melanoma research at the John Wayne Cancer Institute, CA) on my blog.  If study results can impress these guys, then it sure impresses me!  Apart from that, because COMPLETE lymphadenectomy was utilized in every patient in the study group who had a positve sentinel node, this study goes further in answering the quesiton of whether removal of the entire nodal basin is better than simple sentinel node removal alone.  It tells us that complete lymphadenectomy in patients with a positive sentinel node, is therapeutic.

                                      Thanks, Celeste

                                      • February 16, 2014 at 12:02 am
                                      BrianP
                                      Participant

                                        Coincidentally this article about the life of Dr. Morton and his pioneering research on SNB just came out recently.  I remember Tim posting something about Dr. Morton's passing a few weeks ago but I didn't have a real appreciation for what he did for melanoma research.

                                        http://www.nytimes.com/2014/01/20/health/dr-donald-morton-melanoma-expert-who-pioneered-a-cancer-technique-dies-at-79.html?_r=0

                                        • February 16, 2014 at 12:02 am
                                        BrianP
                                        Participant

                                          Coincidentally this article about the life of Dr. Morton and his pioneering research on SNB just came out recently.  I remember Tim posting something about Dr. Morton's passing a few weeks ago but I didn't have a real appreciation for what he did for melanoma research.

                                          http://www.nytimes.com/2014/01/20/health/dr-donald-morton-melanoma-expert-who-pioneered-a-cancer-technique-dies-at-79.html?_r=0

                                          • February 16, 2014 at 12:02 am
                                          BrianP
                                          Participant

                                            Coincidentally this article about the life of Dr. Morton and his pioneering research on SNB just came out recently.  I remember Tim posting something about Dr. Morton's passing a few weeks ago but I didn't have a real appreciation for what he did for melanoma research.

                                            http://www.nytimes.com/2014/01/20/health/dr-donald-morton-melanoma-expert-who-pioneered-a-cancer-technique-dies-at-79.html?_r=0

                                              • February 16, 2014 at 11:14 am
                                              Maureen038
                                              Participant

                                                Thank you Brian for bringing these articles to our attention -very interesting! I also had no idea the pioneering work Dr. Morton achieved. I learned a lot through everyone's post and I truly hope in the near future more options would be available for people with stage 3. 

                                                Maureen

                                                • February 16, 2014 at 11:14 am
                                                Maureen038
                                                Participant

                                                  Thank you Brian for bringing these articles to our attention -very interesting! I also had no idea the pioneering work Dr. Morton achieved. I learned a lot through everyone's post and I truly hope in the near future more options would be available for people with stage 3. 

                                                  Maureen

                                                  • February 16, 2014 at 11:14 am
                                                  Maureen038
                                                  Participant

                                                    Thank you Brian for bringing these articles to our attention -very interesting! I also had no idea the pioneering work Dr. Morton achieved. I learned a lot through everyone's post and I truly hope in the near future more options would be available for people with stage 3. 

                                                    Maureen

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