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2. Outcomes with adjuvant anti-PD-1 therapy in patients with sentinel lymph node-positive melanoma without completion lymph node dissection

Author

Eroglu, Z, Broman, KK, Thompson, JF, Nijhuis, A, Hieken, TJ, Kottschade, L, Farma, JM, Hotz, M, Deneve, J, Fleming, M, Bartlett, EK, Sharma, A, Dossett, L, Hughes, T, Gyorki, DE, Downs, J, Karakousis, G, Song, Y, Lee, A, Berman, RS, van Akkooi, A, Stahlie, E, Han, D, Vetto, J, Beasley, G, Farrow, NE, Hui, JYC, Moncrieff, M, Nobes, J, Baecher, K, Perez, M, Lowe, M, Ollila, DW, Collichio, FA, Bagge, RO, Mattsson, J, Kroon, HM, Chai, H, Teras, J, Sun, J, Carr, MJ, Tandon, A, Babacan, NA, Kim, Y, Naqvi, M, Zager, J, Khushalani, N, Eroglu, Z, Broman, KK, Thompson, JF, Nijhuis, A, Hieken, TJ, Kottschade, L, Farma, JM, Hotz, M, Deneve, J, Fleming, M, Bartlett, EK, Sharma, A, Dossett, L, Hughes, T, Gyorki, DE, Downs, J, Karakousis, G, Song, Y, Lee, A, Berman, RS, van Akkooi, A, Stahlie, E, Han, D, Vetto, J, Beasley, G, Farrow, NE, Hui, JYC, Moncrieff, M, Nobes, J, Baecher, K, Perez, M, Lowe, M, Ollila, DW, Collichio, FA, Bagge, RO, Mattsson, J, Kroon, HM, Chai, H, Teras, J, Sun, J, Carr, MJ, Tandon, A, Babacan, NA, Kim, Y, Naqvi, M, Zager, J, and Khushalani, N

Abstract

Until recently, most patients with sentinel lymph node-positive (SLN+) melanoma underwent a completion lymph node dissection (CLND), as mandated in published trials of adjuvant systemic therapies. Following multicenter selective lymphadenectomy trial-II, most patients with SLN+ melanoma no longer undergo a CLND prior to adjuvant systemic therapy. A retrospective analysis of clinical outcomes in SLN+ melanoma patients treated with adjuvant systemic therapy after July 2017 was performed in 21 international cancer centers. Of 462 patients who received systemic adjuvant therapy, 326 patients received adjuvant anti-PD-1 without prior immediate (IM) CLND, while 60 underwent IM CLND. With median follow-up of 21 months, 24-month relapse-free survival (RFS) was 67% (95% CI 62% to 73%) in the 326 patients. When the patient subgroups who would have been eligible for the two adjuvant anti-PD-1 clinical trials mandating IM CLND were analyzed separately, 24-month RFS rates were 64%, very similar to the RFS rates from those studies. Of these no-CLND patients, those with SLN tumor deposit >1 mm, stage IIIC/D and ulcerated primary had worse RFS. Of the patients who relapsed on adjuvant anti-PD-1, those without IM CLND had a higher rate of relapse in the regional nodal basin than those with IM CLND (46% vs 11%). Therefore, 55% of patients who relapsed without prior CLND underwent surgery including therapeutic lymph node dissection (TLND), with 30% relapsing a second time; there was no difference in subsequent relapse between patients who received observation vs secondary adjuvant therapy. Despite the increased frequency of nodal relapses, adjuvant anti-PD-1 therapy may be as effective in SLN+ pts who forego IM CLND and salvage surgery with TLND at relapse may be a viable option for these patients.

Published
2022

3. Surveillance of Sentinel Node-Positive Melanoma Patients with Reasons for Exclusion from MSLT-II: Multi-Institutional Propensity Score Matched Analysis

Author

Broman, KK, Hughes, TM, Dossett, LA, Sun, J, Carr, MJ, Kirichenko, DA, Sharma, A, Bartlett, EK, Nijhuis, AAG, Thompson, JF, Hieken, TJ, Kottschade, L, Downs, J, Gyorki, DE, Gyorki, JJ, Stahlie, E, van Akkooi, A, Ollila, DW, Frank, J, Song, Y, Karakousis, G, Moncrieff, M, Nobes, J, Vetto, J, Han, D, Farma, J, Deneve, JL, Fleming, MD, Perez, M, Baecher, K, Lowe, M, Bagge, RO, Mattsson, J, Lee, AY, Berman, RS, Chai, H, Kroon, HM, Teras, RM, Teras, J, Farrow, NE, Beasley, GM, Hui, JYC, Been, L, Kruijff, S, Boulware, D, Sarnaik, AA, Sondak, VK, Zager, JS, Broman, KK, Hughes, TM, Dossett, LA, Sun, J, Carr, MJ, Kirichenko, DA, Sharma, A, Bartlett, EK, Nijhuis, AAG, Thompson, JF, Hieken, TJ, Kottschade, L, Downs, J, Gyorki, DE, Gyorki, JJ, Stahlie, E, van Akkooi, A, Ollila, DW, Frank, J, Song, Y, Karakousis, G, Moncrieff, M, Nobes, J, Vetto, J, Han, D, Farma, J, Deneve, JL, Fleming, MD, Perez, M, Baecher, K, Lowe, M, Bagge, RO, Mattsson, J, Lee, AY, Berman, RS, Chai, H, Kroon, HM, Teras, RM, Teras, J, Farrow, NE, Beasley, GM, Hui, JYC, Been, L, Kruijff, S, Boulware, D, Sarnaik, AA, Sondak, VK, and Zager, JS

Abstract

BACKGROUND: In sentinel lymph node (SLN)-positive melanoma, two randomized trials demonstrated equivalent melanoma-specific survival with nodal surveillance vs completion lymph node dissection (CLND). Patients with microsatellites, extranodal extension (ENE) in the SLN, or >3 positive SLNs constitute a high-risk group largely excluded from the randomized trials, for whom appropriate management remains unknown. STUDY DESIGN: SLN-positive patients with any of the three high-risk features were identified from an international cohort. CLND patients were matched 1:1 with surveillance patients using propensity scores. Risk of any-site recurrence, SLN-basin-only recurrence, and melanoma-specific mortality were compared. RESULTS: Among 1,154 SLN-positive patients, 166 had ENE, microsatellites, and/or >3 positive SLN. At 18.5 months median follow-up, 49% had recurrence (vs 26% in patients without high-risk features, p < 0.01). Among high-risk patients, 52 (31%) underwent CLND and 114 (69%) received surveillance. Fifty-one CLND patients were matched to 51 surveillance patients. The matched cohort was balanced on tumor, nodal, and adjuvant treatment factors. There were no significant differences in any-site recurrence (CLND 49%, surveillance 45%, p = 0.99), SLN-basin-only recurrence (CLND 6%, surveillance 14%, p = 0.20), or melanoma-specific mortality (CLND 14%, surveillance 12%, p = 0.86). CONCLUSIONS: SLN-positive patients with microsatellites, ENE, or >3 positive SLN constitute a high-risk group with a 2-fold greater recurrence risk. For those managed with nodal surveillance, SLN-basin recurrences were more frequent, but all-site recurrence and melanoma-specific mortality were comparable to patients treated with CLND. Most recurrences were outside the SLN-basin, supporting use of nodal surveillance for SLN-positive patients with microsatellites, ENE, and/or >3 positive SLN.

Published
2021

4. Active surveillance of patients who have sentinel node positive melanoma: An international, multi-institution evaluation of adoption and early outcomes after the Multicenter Selective Lymphadenectomy trial II (MSLT-2)

Author

Broman, KK, Hughes, T, Dossett, L, Sun, J, Kirichenko, D, Carr, MJ, Sharma, A, Bartlett, EK, Nijhuis, AAG, Thompson, JF, Hieken, TJ, Kottschade, L, Downs, J, Gyorki, DE, Stahlie, E, van Akkooi, A, Ollila, DW, Frank, J, Song, Y, Karakousis, G, Moncrieff, M, Nobes, J, Vetto, J, Han, D, Farma, JM, Deneve, JL, Fleming, MD, Perez, MC, Lowe, MC, Olofsson Bagge, R, Mattsson, J, Lee, AY, Berman, RS, Chai, H, Kroon, HM, Teras, J, Teras, RM, Farrow, NE, Beasley, G, Hui, JYC, Been, L, Kruijff, S, Kim, Y, Naqvi, SMH, Sarnaik, AA, Sondak, VK, Zager, JS, Broman, KK, Hughes, T, Dossett, L, Sun, J, Kirichenko, D, Carr, MJ, Sharma, A, Bartlett, EK, Nijhuis, AAG, Thompson, JF, Hieken, TJ, Kottschade, L, Downs, J, Gyorki, DE, Stahlie, E, van Akkooi, A, Ollila, DW, Frank, J, Song, Y, Karakousis, G, Moncrieff, M, Nobes, J, Vetto, J, Han, D, Farma, JM, Deneve, JL, Fleming, MD, Perez, MC, Lowe, MC, Olofsson Bagge, R, Mattsson, J, Lee, AY, Berman, RS, Chai, H, Kroon, HM, Teras, J, Teras, RM, Farrow, NE, Beasley, G, Hui, JYC, Been, L, Kruijff, S, Kim, Y, Naqvi, SMH, Sarnaik, AA, Sondak, VK, and Zager, JS

Abstract

BACKGROUND: For patients with sentinel lymph node (SLN)-positive cutaneous melanoma, the Second Multicenter Selective Lymphadenectomy trial demonstrated equivalent disease-specific survival (DSS) with active surveillance using nodal ultrasound versus completion lymph node dissection (CLND). Adoption and outcomes of active surveillance in clinical practice and in adjuvant therapy recipients are unknown. METHODS: In a retrospective cohort of SLN-positive adults treated at 21 institutions in Australia, Europe, and the United States from June 2017 to November 2019, the authors evaluated the impact of active surveillance and adjuvant therapy on all-site recurrence-free survival (RFS), isolated nodal RFS, distant metastasis-free survival (DMFS), and DSS using Kaplan-Meier curves and Cox proportional hazard models. RESULTS: Among 6347 SLN biopsies, 1154 (18%) were positive and had initial negative distant staging. In total, 965 patients (84%) received active surveillance, 189 (16%) underwent CLND. Four hundred thirty-nine patients received adjuvant therapy (surveillance, 38%; CLND, 39%), with the majority (83%) receiving anti-PD-1 immunotherapy. After a median follow-up of 11 months, 220 patients developed recurrent disease (surveillance, 19%; CLND, 22%), and 24 died of melanoma (surveillance, 2%; CLND, 4%). Sixty-eight patients had an isolated nodal recurrence (surveillance, 6%; CLND, 4%). In patients who received adjuvant treatment without undergoing prior CLND, all isolated nodal recurrences were resectable. On risk-adjusted multivariable analyses, CLND was associated with improved isolated nodal RFS (hazard ratio [HR], 0.36; 95% CI, 0.15-0.88), but not all-site RFS (HR, 0.68; 95% CI, 0.45-1.02). Adjuvant therapy improved all-site RFS (HR, 0.52; 95% CI, 0.47-0.57). DSS and DMFS did not differ by nodal management or adjuvant treatment. CONCLUSIONS: Active surveillance has been adopted for most SLN-positive patients. At initial assessment, real-world outcomes align with r

Published
2021

7. 93rd annual convention podium and poster abstracts

Author

Davis, C. M., Strong, S. A., Hellinger, M. D., Williamson, P. R., Larach, S. W., Ferrara, A., Blake, T. B., Medich, D. S., Ziv, Y., Oakley, J. R., Reissman, P., Piccirillo, M., Ulrich, A., Nogueras, J. J., Wexner, S. D., Rubin, M. S., Bodenstein, L. E., Kent, K. C., Williamson, M. E. R., Lewis, W. G., Sagar, P. M., Holdsworth, P. J., Johnston, D., Fazio, V. W., Goldblum, J. R., Sirimarco, M. T., Lavery, I. C., Petras, R. E., Treem, W. R., Cohen, J., Davis, P. M., Hyams, J. S., Eu, K. W., Bartolo, D. C. C., Green, J. D., Riether, R. D., Rosen, L., Stasik, J. J., Sheets, J. A., Reed, J., Khubchandani, I. T., Armitage, N. C., Chapman, M., Hardcastle, J. D., Viamonte, M., Plasencia, G., Wiltz, O., Jacobs, M., Finan, P. J., Passaro, M., Church, J. M., McGannon, E., Wilson, M., Hull-Boiner, S., Kollmorgen, C. F., Meagher, A. P., Wolff, B. G., Pemberton, J. H., Martenson, J. A., Ilstrup, D. M., Moran, M. R., Ramos, A., Rothenberger, D. A., Goldberg, S. M., Johnson, D., Madoff, R. D., Wong, W. D., Finne, III, C. O., Konishi, F., Furuta, K., Kanazawa, K., Lockhart, D., Schmitt, S., Caushaj, P. P., Garcia-Aguilar, J., Belmonte, C., Schiesel, E. C., Mazier, W. P., Senagore, A. J., Piccirillo, M. F., Teoh, T. -A., Yoon, K. -S., Paul, R. A. Patino, Lucas, J., Nelson, R., Norton, N., Cautley, E., Schouten, W. R., Briel, J. W., Auwerda, J. J. A., de Graaf, E. J. R., Lowry, A. C., Sentovich, S. M., Blatchford, G. J., Rivela, L. J., Thorson, A. G., Christensen, M. A., Jorge, J. M. N., Yang, Y. K., Shafik, A., Allendorf, J. D. F., Kayton, M. L., Libutti, S. K., Trokel, M. J., Whelan, R. L., Treat, M. R., Nowygrod, R., Bessler, M., Frank, R. E., Saclarides, T. J., Leurgans, S., Speziale, N. J., Drab, E., Rubin, D., Hull, T. L., Schroeder, T. K., Scholefield, J. H., Ogunbiyi, O. A., Smith, J. H. F., Rogers, K., Sharp, F., Longo, W. E., Vernava, III, A. M., Wade, T. P., Coplin, M. A., Virgo, K. S., Johnson, F. E., Brady, M., Kavolius, J., Quan, S. H. Q., Goldstein, E. T., Feldman, S., Shub, H. A., Bennett, D. R., Kumar, R., McMillen, M. A., Thornton, S., Khoury, D. A., Opelka, F. G., Teoh, T -A., Cohen, S. M., Weiss, E. G., Ortiz, H., De Miguel, M., Armendáriz, P., Rodriguez, J., Chocarro, C., Farouk, R., Dorrance, H. R., Duthie, G. S., Rainey, J. B., Morgado, Jr., P. J., Corman, M. L., Kawamura, Y. J., Sawada, T., Muto, T., Nagai, H., Hill, J., MacLennan, I., Binderow, S. R., Daniel, N., Ehrenpreis, E. D., Jensen, J. E., Bonner, G. F., Ruderman, W. B., Milsom, J. W., Gibbs, D. H., Beck, D. E., Hicks, T. C., Timmcke, A. E., Gathright, Jr, J. B., Cheong, D., Lucas, F. V., McGinity, M., Taylor, B. A., Godwin, P., Holdsworth, P., Lewis, W., Quirke, P., Williamson, M., Kokoszka, J., Pavel, D., Abcarian, H., Stephenson, B. M., Morgan, A. R., Salaman, J. R., Wheeler, M. H., Tran, T. C. K., Willemsen, W., Kuijpers, H. C., Lehman, J. F., Wiseman, J. S., MacFie, J., Sedman, P., May, J., Mancey-Jones, B., Johnstone, D., Nwariaku, F. E., Rochon, R. B., Huber, P. J., Carrico, C. J., Ortega, A., Beart, R., Winchester, D., Steele, G., Green, R., Caushaj, P. F., Devereaux, D., Griffey, S., Reiver, D., Kmiot, W. A., Baker, R., Luchtefeld, M. A., Anthone, G., Schlinkert, R., Roig, J. V., Villoslada, C., Solana, A., Alos, R., Hinojosa, J., Lledo, S., Johnson, D. R. E., Buie, W. D., Jensen, L. L., Heine, J., Hoffmann, B., Timmcke, A., Hicks, T., Opelka, F., Beck, D., Sousa, Jr., A., AraÚjo, S. A., Damico, F. M., Cordeiro, A. C., Pinotti, H. W., Gama, A. H., Fengler, S., Pearl, R., Orsay, C., Seow-Choen, F., Ho, J. M. S., Wiltz, O. H., Torregrosa, M., Brasch, R. C., Bufo, A. J., Krienberg, P., Johnson, G. P., Gowen, G. F., Mullen, P. D., Behrens, D., Hughes, T. G., Wynn, M., Pollack, J. S., Rajagopal, A. S., Huynh, T., Schanbacher, C., Hickson, W. G. E., Yang, Y. -K., Heymen, S., Choi, S. -K., Teoh, T. -A., Wexner, S. D., Vaccaro, C. A., Teoh, T. A., Nogueras, J. J., Choi, S. K., Cheong, D. M. O., Salanga, V. D., MacDonald, A., Baxter, J. N., Finlay, I. G., Mellgren, A., Bremmer, S., Dolk, A., Gillgren, P., Johansson, C., Ahlbäck, S. O., Udén, R., Holmström, B., Ferrara, A., O'Donovan, S., Larach, S. W., Williamson, P. R., Neto, J. A. Reis, Ciquini, S., Quilici, F. A., Reis, Jr., J. A., Torrabadella, L., Salgado, G., Whelan, R. L., Horvath, K. D., Golub, R., Ahsan, H., Cirocco, W., Ziv, Y., Fazio, V. W., Oakley, J. R., Church, J. M., Milsom, J. W., Lavery, L. C., Cohen, S. M., Kmiot, W. A., Reiver, D., Reissman, P., Weiss, E. G., Alós, R., García-Granero, E., Roig, J. V., Uribe, N., Sala, C., Lledo, S., Ozuner, G., Strong, S. A., Bufo, A. J., Daniels, G., Lieberman, R. C., Feldman, S., Lucas, F. V., Longo, W. E., Polites, G., Deshpande, Y., Vernava, A. M., Niehoff, M., Chandel, B., Berglund, D. D., Madoff, R. D., Gemlo, B. T., Spencer, M. P., Goldberg, S. M., Lowry, A. C., Marcello, P. W., Roberts, P. L., Schoetz, D. J., Murray, J. J., Coller, J. A., Veidenheimer, M. C., Koltun, W. A., Bloomer, M. M., Colony, P., Ruggeiro, F., Fleshner, P. R., Michelassi, F., Lewis, W., Williamson, M., Holdsworth, P., Finan, P., Ash, D., Johnston, D., Moran, M. R., Ramos, A., Rothenberger, D. A., Antonenko, D. R., Khanduja, K. S., Fitzgerald, S. D., Meagher, A. P., Moniz-Pereira, P., Wolff, B. G., Outwater, E. K., Marks, G. J., Mohiuddin, M., Sagar, P. M., Hartley, M. N., Mancey-Jones, B., Sedman, P., May, J., MacFie, J., Holbrook, R. F., Rodriguez-Bigas, M. A., Ramakrishnan, K., Palmer, M. L., Petrelli, N. J., Takahashi, T., Nivatvongs, S., Batts, K. P., Lucas, S. W., Klein, S. N., Keidan, R. D., Bannon, J. P., Zhou, J., Armitage, N. C., Hunt, L. M., Robinson, M. H., Hugkulstone, C. E., Clarke, B., Vernon, S. A., Gregson, R. H., Hardcastle, J. D., Ryan, M., Dutta, S., Levine, A., Ortega, A., Anthone, G., Beart, R., Dominguez, J. M., Saclarides, T. J., Bolan, P., Bines, S. D., Adachi, M., Watanabe, T., Sawada, T., Okinaga, K., Muto, T., Hase, K., Shatney, C., Mochizuki, H., Johnson, D., Ure, T., Dehghan, K., Andrus, C. A., Daniel, G. L., D'Emilia, J. C., Rodriguez-Bigas, M., Suh, O. K., Brewer, D. A., Fung, C., Chapuis, P., Bokey, E. L., Garcia, J. C., Banerjee, S., Remzi, F. H., Lavery, I. C., Jorge, J. M. N., Ger, G. C., Gonzalez, L., Gee, A. S., Roe, A. M., Durdey, P., Kaye, M. D., Kyzer, S., Gordon, P. H., Hasegawa, M., Bun, P. Tae, Ikeuchi, D., Onodera, H., Imamura, M., Maetani, S., Blake, T., Hellinger, M., Grewal, H., Klimstra, D. S., Cohen, A. M., Guillem, J. G., Rooney, P. S., Gifford, K. -A., Clarke, P. A., Kuhn, J. A., Bryce, K., Frank, N., Dignan, R. D., Lichliter, W. E., Franko, E., Jacobson, R. M., Preskitt, J. T., Lieberman, Z., Tulanon, P., Steinbach, H., McCarty, T., Simons, T., Plasencia, G., Viamonte, M., Wiltz, O., Jacobs, M., Chen, W. S., Leu, S. Y., Hsu, H., Bessler, M., Halverson, A., Kayton, M. L., Treat, M. R., Nowygrod, R., Congilosi, S., Madoff, R., Wong, W. D., Rothenberger, D., Buie, W. D., Paterson, R., Cartmill, J. A., Trokel, M. J., Gingold, B. S., Cooper, M., Gorfine, S. R., Bauer, J. J., Gelernt, I. M., Kreel, I., Harris, M. T., Vallejo, J. F., Kestenberg, A., Miyajima, N., Kano, N., Ishikawa, Y., Sakai, S., Yamakawa, T., Otchy, D. P., Van Heerden, J. A., Ilstrup, D. M., Weaver, A. L., Winter, L. D., Mav, J., Lee, P. Y., Vetto, J. T., Sullivan, E. S., Rabkin, J., Mayoral, J. L., Matas, A. J., Bove, P., Visser, T., Barkel, D., Villalba, M., Bendick, P., Glover, J., Golub, R. W., Cirocco, W. C., Daniel, N., Altringer, W., Domingues, J. M., Brubaker, L. T., Smith, C. S., Kumar, S., and Gilbert, P.

Published
1994
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8. Poster Presentations

Author

Mitra, A., Walker, S. A., Bayer, I., Pickovsky, B., Cohen, S. M., Schmitt, S. L., Lucas, F. L., Wexner, S. D., Szilagy, E. J., Ryan, J. B., Williams, J. G., Deen, K. I., Grant, E., Kumar, D., Wiltz, O. H., Garcia, J. E., Feliciano, R., Martino, J., Solomon, M., McLeod, R. S., O'Connor, B., Steinhart, H., Greenberg, G., Cohen, Z., Meagher, A. P., Adams, W. J., Lubowski, D. Z., Ellis, C. N., Boggs, H. W., Coyle, D. J., Blakemore, W. S., Nahas, S. C., Ibrahim, R. El, Pinotti, H. W., Palakanis, K., DeNobile, J., Sweeney, B., Blankenship, C., Sun, J. H., Stiegmann, G. V., Kim, J. G., Pearlman, N. W., Landes, R. V., Hankin, R. C., Barkel, D. C., Beauregard, W. L., Poulik, M. D., Chen, J. C., Dmuchowski, C., Cho, E., Lee, P. Y., Fletcher, W. S., Sullivan, E. S., Vetto, J. T., Hull, T. L., Lavery, I. C., Saxton, J. P., McCue, J., Sheffield, J., Phillips, R., DiPierro, J., Milsom, J. W., Fazio, V. W., Strong, S. A., Vernava, III, A. M., Longo, W. E., Wade, T. P., Virgo, K. S., Coplin, M. A., Johnson, F. E., Cavina, E., Menconi, C., Ghiselli, G., Seccia, M., Tjandra, J. J., Lowndes, R., McKirdy, H., Schroeder, T., Hughes, L. E., Sentovich, S. M., Rivela, L. J., Thorson, A. G., Blatchford, G. J., Christensen, M. A., Jensen, L. L., Lowry, A. C., Miller, R., Mills, A., Durdey, P., Hock-Saive, D., Lombard, R., Jehaes, C., Markiewicz, S., Penders, L., Fontaine, F., Cusumano, P., Nelissen, G., MacDonald, A., Baxter, J. N., Bessent, R. G., Gray, H. W., Finlay, I. G., Duthie, G. S., Farouk, R., Bartolo, D. C. C., Ramanujam, P. S., Venkatesh, K. S., Oliver, G. C., Vachon, D., Eisenstat, T. E., Rubin, R. J., Salvati, E. P., Dorsey-Tyler, K. R., Harmon, G., Medwell, S. J., Binderow, S. R., Noguerás, J. J., Jagelman, D. G., Decanini, C., Bohm, B., Stolfi, V. W., Cataldo, P. A., Hadick, C., Resnikov, P., Mellinger, J. D., Cunningham, B., Vayer, Jr., A. J., Larach, S. W., Williamson, P. R., Ferrara, A., Salomon, M., Nogueras, J. J., Sullivan, J., Staniunas, R. J., Keck, J. O., Counihan, T., Marcello, P., Barrett, R. C., Oster, M., Roberts, P. L., Schoetz, D. J., Murray, J. J., Veidenheimer, M. C., Coller, J. A., Sagar, P. M., Lewis, W., Williamson, M., Holdsworth, P. J., Johnston, D., Jorge, J. M. N., Morgado, Jr., P. J., James, K., Morgado, Jr., P., Penna, C., Kartheuser, A., Tiret, E., Parc, R., McIntyre, P. B., Pemberton, J. H., Wolff, B. G., Dozois, R. R., Beart, R. W., Kelley, K. A., Harrison, J. B., Hockenberry, S. E., Williamson, M. E. R., Lewis, W. G., Sagar, P., Armstrong, D. N., Collopy, B. C., Ryan, P. J., Fink, R., Mackay, J. R., Woods, R. J., Nazarian, H. K., Kong, L. B., Fleshner, P. R., Keighley, M. R. B., Farmakis, N., Tudor, R., Wiltz, O., Wong, W. D., Goldberg, S. M., Rothenberger, D. A., Arnold, M. W., Schneebaum, S., Martin, Jr., E. W., Young, D. C., Schechter, S., Snyder, M. L., Orkin, B. A., Smith, L. E., Dean, P. A., Ramsey, P. S., Nelson, H., Barker, G., Neoptolomos, J. P., Patel, R. T., Pall, A., and Adu, D.

Published
1993
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9. Immunological and Molecular Analysis of the Sentinel Lymph Node: A Potential Approach to Predict Outcome, Tailor Therapy, and Optimize Parameters for Tumor Vaccine Development

Author

Meijer, S. L., Dols, A., Hu, H M., Jensen, S., Poehlein, C. H., Chu, Y., Winter, H., Yamada, J., Moudgil, T., Wood, W. J., Doran, T., Justice, L., Fisher, B., Wisner, P., Wood, J., Vetto, J. T., Mehrotra, R., Rosenheim, S., Weinberg, A. D., Bright, R., Walker, E., Puri, R., Smith, J. W, II, Urba, W. J., and Fox, B. A.

Published
2001

10. Subgroup analysis of a phase II multicenter trial of HF10, oncolytic virus immunotherapy, and ipilimumab combination treatment in unresectable or metastatic melanoma patients

Author

Andtbacka, R.H.I., primary, Ross, M., additional, Agarwala, S.S., additional, Taylor, M., additional, Vetto, J., additional, Neves, R.I., additional, Daud, A., additional, Khong, H.T., additional, Ungerleider, R.S., additional, Tanaka, M., additional, and Grossmann, K.F., additional

Published
2017
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12. Tumor response from phase II study of combination treatment with intratumoral HF10, a replication-competent HSV-1 oncolytic virus, and ipilimumab in patients with stage IIIB, IIIC, or IV unresectable or metastatic melanoma

Author

Andtbacka, R., primary, Ross, M., additional, Agarwala, S.S., additional, Taylor, M., additional, Vetto, J., additional, Neves, R.I., additional, Daud, A., additional, Khong, H., additional, Ungerleider, R.S., additional, Welden, S., additional, Tanaka, M., additional, and Grossmann, K., additional

Published
2016
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14. Impact of sentinel node status and other risk factors on the clinical outcome of head and neck melanoma patients

Author

Leong, SPL, Accortt, NA, Essner, R, Ross, M, Gershenwald, JE, Pockaj, B, Hoekstra, HJ, Garberoglio, C, White, RL, Biel, M, Charney, K, Wanebo, H, Avisar, E, Vetto, J, and Soong, SJ

Subjects
EARLY-STAGE MELANOMA, LYMPH-NODES, CUTANEOUS MELANOMA, BIOPSY, PATTERNS, EXPERIENCE, RECURRENCE, CANCER, LYMPHADENECTOMY, MALIGNANT-MELANOMA
Abstract

Objective: To determine the impact of sentinel lymph node (SLN) status and other risk factors on recurrence and overall survival in head and neck melanoma patients. Design: The SLN Working Group, based in San Francisco, Calif, with its 11 member centers, the John Wayne Cancer Institute, and The University of Texas M. D. Anderson Cancer Center pooled data on 629 primary head and neck melanoma patients who had selective sentinel lymphadenectomy. A total of 614 subjects were analyzable. All centers obtained internal review board approval and adhered to the Health Insurance Portability and Accountability Act of 1996 regulations. A Cox proportional hazards model was used to identify factors associated with overall and disease-free survival. Setting: Tertiary care medical centers. Main Outcome Measure: Clinical outcome of head and neck melanoma patients undergoing selective sentinel lymphadenectomy. Results: Overall, 10.1% (n=62) of the subjects had at least 1 positive node. Subjects with positive SLN status had significantly thicker tumors (mean thickness, 2.8 vs 2.1 mm; P Conclusion: In this multicenter study, SLN status and other risk factors have an effect on recurrence and/or overall survival.

Published
2006

20. Wedge resection vs lobectomy: 10-year survival in stage I primary lung cancer.

Author

Kraev A, Rassias D, Vetto J, Torosoff M, Ravichandran P, Clement C, Kadri A, and Ilves R

Abstract

BACKGROUND: The selection of lobectomy or wedge resection in the treatment of patients with stage I primary lung cancer remains controversial. Clinical judgment based on comorbidities remains the main decision factor. We investigated the impact of procedure on long-term survival in a multicenter retrospective analysis. METHODS: The records of 289 patients who underwent surgical resection of stage I primary lung cancer between 1993 and 1998 at three tertiary medical centers were reviewed for age, sex, type of resection, tumor size, number of lymph nodes dissected, pathology, and recurrence. Long-term survival was obtained through the Federal Social Security Death Index and Cancer Registries. Kaplan-Meier, Wilcox, logistic regression, and power and t test analyses were used to examine survival, predictors of mortality, and correlations. RESULTS: A total of 215 patients underwent lobectomy, and 74 underwent wedge resection. The groups were similar with respect to age, tumor size, and other comorbidities. Overall, there was a nonsignificant trend toward better survival times in patients after lobectomy vs wedge resection (mean [+/- SD] survival time, 5.8 +/- 0.3 vs 4.1 +/- 0.3 years, respectively; p = 0.112). This trend gained significance in smaller cancers, where patients who underwent lobectomy for tumors < 3 cm in size had better survival times compared to those who underwent wedge resection (p = 0.029). CONCLUSION: Although the overall difference in survival time between patients undergoing lobectomy and those undergoing wedge resection was not significant, patients with tumors < 3 cm in size had improved survival times after undergoing lobectomy. Thus, tumor size appears to be an important factor to be considered in preoperative planning. Randomized trials are necessary to confirm the superiority of lobectomy over wedge resection for stage IA lung cancers. [ABSTRACT FROM AUTHOR]

Published
2007
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35. Concurrent preoperative eribulin and radiation for resectable retroperitoneal liposarcoma: a phase 1B study.

Author

Davis L, Zhu L, Mayo SC, Latour E, Park B, Huang W, Moloney B, Davis JL, Wakeman K, Sheppard B, Billingsley KG, Vetto J, Valenzuela CD, Eil RL, Rocha F, Hung A, and Ryan CW

Abstract

Background: Management of retroperitoneal liposarcoma (RPLPS) is challenging and recurrence rates remain high despite aggressive surgical resections. Preoperative radiation alone lacks definitive benefit, thus we sought to evaluate combined chemoradiotherapy with the potential to enhance local efficacy of radiation as well as control micrometastatic disease. We assessed the safety and tolerability of preoperative eribulin, a cytotoxic microtubule inhibitor approved for the treatment of advanced liposarcoma, in combination with radiation in patients with RPLPS., Methods: In this open-label dose-finding study, patients with primary or recurrent resectable RPLPS received preoperative intensity-modulated radiation therapy (IMRT) with escalating doses of eribulin. Eribulin was administered for three 21-day cycles at a starting dose of 1.1 mg/m 2 . Concurrent radiation to 50.4 Gy began during cycle 1. Surgical resection occurred 3-10 weeks after completion of chemoradiation. The primary endpoint was determination of the recommended phase 2 doses (RP2D) of concurrent eribulin and radiation., Results: Between 2018-2023, fifteen patients were enrolled. Thirteen patients were evaluable for dose-determination. Four patients treated at starting dose level had no dose-limiting toxicities (DLTs). Two of nine patients treated with escalated eribulin dose had DLTs. The RP2D was established as eribulin 1.4 mg/m 2 and IMRT 50.4 Gy. Eleven patients were evaluable for secondary efficacy endpoints. The median recurrence-free survival was 30.4 months (95% CI 12.0-NR) and the median overall survival was 54.1 months (95% CI 9.5-NR). Patient reported outcome data did not show any significant changes over the study period., Conclusion: A preoperative chemoradiation protocol of eribulin in combination with IMRT showed a manageable safety profile and warrants additional prospective evaluation for treatment of resectable RPLPS., Competing Interests: Competing interests: The authors declare that they have no competing interests.

Published
2024
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37. Routine imaging guided by a 31-gene expression profile assay results in earlier detection of melanoma with decreased metastatic tumor burden compared to patients without surveillance imaging studies.

Author

Dhillon S, Duarte-Bateman D, Fowler G, Hagstrom MNE, Lampley N, Olivares S, Fumero-Velázquez MS, Vu K, Wayne JD, Gastman BR, Vetto J, and Gerami P

Subjects
Humans, Transcriptome, Retrospective Studies, Tumor Burden, Neoplasm Recurrence, Local pathology, Neoplasm Staging, Prognosis, Melanoma, Cutaneous Malignant, Melanoma diagnosis, Melanoma genetics, Melanoma pathology, Skin Neoplasms diagnosis, Skin Neoplasms genetics, Skin Neoplasms pathology
Abstract

Patients with early-stage disease typically have a good prognosis, but still have a risk of recurrence, even with negative sentinel lymph node biopsy (SLNB). This study explores the utility of routine imaging to detect metastases in patients with negative SLNB but high-risk 31 gene expression profile (31-GEP) scores. We retrospectively identified melanoma patients with negative SLNBs. Patients with high-risk GEP results were placed in the experimental group and patients without GEP testing were placed in the control group. Among both cohorts, recurrent melanoma groups were identified. The tumor burden at the time of recurrence and the time to recurrence were compared between experimental group patients with routine imaging and control group patients without imaging schedules. We identified 327 control patients and 307 experimental patients, of which 14.1% versus 20.5% had melanoma recurrence, respectively. Of the patients with recurrent melanoma, those in the experimental group were older (65.75 versus 59.20), had higher Breslow depths (3.72 mm versus 3.31 mm), and had advanced tumor staging (89.5% versus 71.4% of patients presenting clinical stage ≥ II) compared to the control group at primary diagnosis. However, melanoma recurrence was detected earlier (25.50 months versus 35.35 months) in the experimental group at a lower overall tumor burden (73.10 mm versus 27.60 mm). A higher percentage of experimental patients started immunotherapy when offered (76.3% and 67.9%). Patients who received routine imaging after high-risk GEP test scores had an earlier recurrence diagnosis with lower tumor burden, leading to better clinical outcomes., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Published
2023
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39. International Center-Level Variation in Utilization of Completion Lymph Node Dissection and Adjuvant Systemic Therapy for Sentinel Lymph Node-Positive Melanoma at Major Referral Centers.

Author

Broman KK, Hughes TM, Bredbeck BC, Sun J, Kirichenko D, Carr MJ, Sharma A, Bartlett EK, Nijhuis AAG, Thompson JF, Hieken TJ, Kottschade L, Downs J, Gyorki DE, Stahlie E, van Akkooi A, Ollila DW, O'shea K, Song Y, Karakousis G, Moncrieff M, Nobes J, Vetto J, Han D, Hotz M, Farma JM, Deneve JL, Fleming MD, Perez M, Baecher K, Lowe M, Bagge RO, Mattsson J, Lee AY, Berman RS, Chai H, Kroon HM, Teras J, Teras RM, Farrow NE, Beasley GM, Hui JYC, Been L, Kruijff S, Sinco B, Sarnaik AA, Sondak VK, Zager JS, and Dossett LA

Subjects
Adult, Humans, Sentinel Lymph Node Biopsy, Cohort Studies, Lymph Node Excision, Retrospective Studies, Sentinel Lymph Node surgery, Sentinel Lymph Node pathology, Skin Neoplasms surgery, Melanoma surgery, Melanoma drug therapy
Abstract

Objective: The aim of this study was to determine overall trends and center-level variation in utilization of completion lymph node dissection (CLND) and adjuvant systemic therapy for sentinel lymph node (SLN)-positive melanoma., Summary Background Data: Based on recent clinical trials, management options for SLN-positive melanoma now include effective adjuvant systemic therapy and nodal observation instead of CLND. It is unknown how these findings have shaped practice or how these contemporaneous developments have influenced their respective utilization., Methods: We performed an international cohort study at 21 melanoma referral centers in Australia, Europe, and the United States that treated adults with SLN-positive melanoma and negative distant staging from July 2017 to June 2019. We used generalized linear and multinomial logistic regression models with random intercepts for each center to assess center-level variation in CLND and adjuvant systemic treatment, adjusting for patient and disease-specific characteristics., Results: Among 1109 patients, performance of CLND decreased from 28% to 8% and adjuvant systemic therapy use increased from 29 to 60%. For both CLND and adjuvant systemic treatment, the most influential factors were nodal tumor size, stage, and location of treating center. There was notable variation among treating centers in management of stage IIIA patients and use of CLND with adjuvant systemic therapy versus nodal observation alone for similar risk patients., Conclusions: There has been an overall decline in CLND and simultaneous adoption of adjuvant systemic therapy for patients with SLN-positive melanoma though wide variation in practice remains. Accounting for differences in patient mix, location of care contributed significantly to the observed variation., Competing Interests: The authors report no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Published
2023
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40. Clinical Utility of Dermoscopy and 31-Gene Expression Profiling by Dermatology Providers in Melanoma Management Care.

Author

Witkowski A, Lee C, Latour E, Vetto J, and Ludzik J

Subjects
Humans, Dermoscopy, Retrospective Studies, Gene Expression Profiling methods, Melanoma, Cutaneous Malignant, Dermatology methods, Melanoma diagnosis, Melanoma genetics, Melanoma pathology
Abstract

Objective: A 31-gene expression profile (31-GEP) test that predicts metastatic risk in patients with cutaneous malignant melanoma (CMM) has previously been validated and is available for clinical use. The test dichotomizes patients into lower risk and higher risk groups based on differences that correspond to unique genetic expression patterns. Although the impact of such a test on dermatology providers' clinical decision-making has been studied, little is known about whether there exists an association between certain clinical features, such as dermoscopy, and 31-GEP results., Methods: In this retrospective analysis of 31-GEP test results ordered by dermatologists, we evaluated the frequency of dermoscopic features, using a modified dermoscopy three-point checklist, in 17 cases (n=17) and compared these findings to other key clinicopathologic features including tumor thickness, ulceration, and mitotic rate to 31-GEP results. Additionally, we evaluated the dermatologist's perspective and incorporation of GEP testing as part of patient discussion on melanoma management., Results: 31-GEP stratified patients into 4 groups; groups 1A and 1B are considered low risk of metastasis or recurrence, while 2A and 2B are considered high risk. Of the 17 cases, we had fifteen group 1A (88.23%), one 1B (5.88%), and one 2B (5.88%) result. Overall frequency of dermoscopic features is as follows; 100% of lesions presented with asymmetry, 47% with round structures, and 70.6% with blue-white color. The average time providers spent explaining and ordering the test was 15 minutes, with a range of 10 to 20 minutes., Conclusions: This study represents our experience and understanding of the dermatologist&rsquo;s role ordering 31-GEP in the care pathway of melanoma patients and we recommend that dermatology providers consider ordering the test for newly diagnosed CMM patients. J Drugs Dermatol. 2022;21(12): doi:10.36849/JDD.6889.

Published
2022
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41. Outcomes with adjuvant anti-PD-1 therapy in patients with sentinel lymph node-positive melanoma without completion lymph node dissection.

Author

Eroglu Z, Broman KK, Thompson JF, Nijhuis A, Hieken TJ, Kottschade L, Farma JM, Hotz M, Deneve J, Fleming M, Bartlett EK, Sharma A, Dossett L, Hughes T, Gyorki DE, Downs J, Karakousis G, Song Y, Lee A, Berman RS, van Akkooi A, Stahlie E, Han D, Vetto J, Beasley G, Farrow NE, Hui JYC, Moncrieff M, Nobes J, Baecher K, Perez M, Lowe M, Ollila DW, Collichio FA, Bagge RO, Mattsson J, Kroon HM, Chai H, Teras J, Sun J, Carr MJ, Tandon A, Babacan NA, Kim Y, Naqvi M, Zager J, and Khushalani NI

Subjects
Humans, Lymph Node Excision, Neoplasm Recurrence, Local pathology, Retrospective Studies, Sentinel Lymph Node Biopsy, Melanoma pathology, Sentinel Lymph Node pathology, Skin Neoplasms drug therapy
Abstract

Until recently, most patients with sentinel lymph node-positive (SLN+) melanoma underwent a completion lymph node dissection (CLND), as mandated in published trials of adjuvant systemic therapies. Following multicenter selective lymphadenectomy trial-II, most patients with SLN+ melanoma no longer undergo a CLND prior to adjuvant systemic therapy. A retrospective analysis of clinical outcomes in SLN+ melanoma patients treated with adjuvant systemic therapy after July 2017 was performed in 21 international cancer centers. Of 462 patients who received systemic adjuvant therapy, 326 patients received adjuvant anti-PD-1 without prior immediate (IM) CLND, while 60 underwent IM CLND. With median follow-up of 21 months, 24-month relapse-free survival (RFS) was 67% (95% CI 62% to 73%) in the 326 patients. When the patient subgroups who would have been eligible for the two adjuvant anti-PD-1 clinical trials mandating IM CLND were analyzed separately, 24-month RFS rates were 64%, very similar to the RFS rates from those studies. Of these no-CLND patients, those with SLN tumor deposit >1 mm, stage IIIC/D and ulcerated primary had worse RFS. Of the patients who relapsed on adjuvant anti-PD-1, those without IM CLND had a higher rate of relapse in the regional nodal basin than those with IM CLND (46% vs 11%). Therefore, 55% of patients who relapsed without prior CLND underwent surgery including therapeutic lymph node dissection (TLND), with 30% relapsing a second time; there was no difference in subsequent relapse between patients who received observation vs secondary adjuvant therapy. Despite the increased frequency of nodal relapses, adjuvant anti-PD-1 therapy may be as effective in SLN+ pts who forego IM CLND and salvage surgery with TLND at relapse may be a viable option for these patients., Competing Interests: Competing interests: ZE: Advisory boards: Array, Pfizer, OncoSec, Regeneron, Genentech, Novartis, Natera. Research funding: Novartis, Pfizer, Boehringer-Ingelheim. JFT: Advisory boards: BMS Australia, MSD Australia, GSK, Provectus Inc. Travel support: GSK, Provectus Inc and Novartis. TJH: Research funding: Genentech, SkylineDX. EKB: Research funding: SkylineDx, Honorarium: Excite International inc. DEG: Honoraria: BMS, Novartis, Q biotics. GK; Advisory Board: Merck. AVA: Advisory Boards: Amgen, Bristol-Myers Squibb, Novartis, MSD-Merck, Merck-Pfizer, Pierre Fabre, Provectus, Sanofi, Sirius Medical, 4SC Research funding: Amgen, Merck-Pfizer. JV: Speaker: Caste Biosciences. GB: Research funding: Istari Oncology, Delcath, Oncosec Medical, Replimune, Checkmate Pharmaceuticals. ROB: Advisory boards: Amgen, BD/BARD, Bristol-Myers Squibb, Merck Sharp & Dohme, Novartis, Roche and Sanofi Genzyme. Research funding: Bristol-Myers Squibb, SkyLineDx. Speaker honorarium: Roche and Pfizer. Shareholder in SATMEG Ventures AB. NIK: Advisory boards: Bristol-Myers Squibb, AstraZeneca, Regeneron, Array, Immunocore, Merck, Incyte, Jounce Therapeutics,Pfizer,Novartis, Nektar,Castle Biosciences, Instil Bio. Research funding: Bristol-Myers Squibb, Merck, Novartis, Celgene, Replimune, Amgen, Regneron, HUYA, GlaxoSmithKline Stocks: Bellicum Pharmaceuticals, Amarin Corporation, Asensus Surgical., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2022
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42. Efficacy of Abemaciclib in the Management of Refractory Metastatic Extramammary Paget's Disease.

Author

Takahashi GW, Vetto J, Leitenberger JJ, and Hung A

Abstract

Published systemic therapy options for metastatic extramammary Paget's disease have largely been anecdotal due to the rarity of this disease, which has precluded the ability to conduct clinical trials. We describe the favorable response of a 72-year-old man with extramammary Paget's disease, whose disease has been controlled with the CDK4/6 inhibitor, abemaciclib. The rationale behind the selection of this therapy is discussed., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2022, Takahashi et al.)

Published
2022
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44. Regression in melanoma is significantly associated with a lower regional recurrence rate and better recurrence-free survival.

Author

Subramanian S, Han G, Olson N, Leong SP, Kashani-Sabet M, White RL, Zager JS, Sondak VK, Messina JL, Pockaj B, Kosiorek HE, Vetto J, Fowler G, Schneebaum S, and Han D

Subjects
Aged, Female, Humans, Lymphatic Metastasis, Male, Melanoma pathology, Middle Aged, Sentinel Lymph Node pathology, Sentinel Lymph Node surgery, Melanoma mortality, Neoplasm Recurrence, Local epidemiology
Abstract

Background and Objectives: The prognostic significance of regression in predicting melanoma recurrences is unknown. We present a large multicenter study correlating regression with recurrence., Methods: The Sentinel Lymph Node Working Group database was queried from 1993 to 2018 for cases with regression data. Clinicopathologic factors were correlated with overall and first-site of recurrence and with recurrence-free survival (RFS)., Results: There were 4790 patients and the median follow-up was 39.6 months. Regression and recurrences were seen in 1081 (22.6%) and 773 (16.1%) cases, respectively. First-site locoregional and distant recurrences were seen in 412 (8.6%) and 352 (7.3%) patients, respectively. Regression was seen in 15.8% and 24.7% of all cases with and without recurrences (p < 0.0001), respectively, while regression was seen in 14.3% and 17.9% of first-site locoregional and distant recurrent cases, respectively, compared with 23.3% and 22.9% of patients with regression and without first-site locoregional and distant recurrences, respectively (p = 0.29). On multivariable analysis, after controlling for age, gender, thickness, ulceration, lymphovascular invasion, and sentinel lymph node status, regression significantly predicted improved RFS (p = 0.004) and fewer first-site regional recurrences (p = 0.017)., Conclusion: Our data suggest that regression is a favorable prognostic marker in melanoma and predicts significantly better RFS and decreased first-site regional recurrences., (© 2021 Wiley Periodicals LLC.)

Published
2022
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45. Regression is significantly associated with outcomes for patients with melanoma.

Author

Subramanian S, Han G, Olson N, Leong SP, Kashani-Sabet M, White RL, Zager JS, Sondak VK, Messina JL, Pockaj B, Kosiorek HE, Vetto J, Fowler G, Schneebaum S, and Han D

Subjects
Aged, Female, Humans, Lymphatic Metastasis, Male, Melanoma pathology, Middle Aged, Retrospective Studies, Melanoma mortality, Neoplasm Regression, Spontaneous
Abstract

Background: The prognostic significance of regression in melanoma is debated. We present a large multicenter study correlating regression with sentinel lymph node metastasis and melanoma-specific survival., Methods: The Sentinel Lymph Node Working Group database was reviewed from 1993 to 2018. Patients with known regression and sentinel lymph node status were included. Clinicopathologic factors were correlated with regression, sentinel lymph node status, and melanoma-specific survival., Results: There were 4,790 patients; median follow-up was 39.6 months. Regression was present in 1,081 (22.6%) cases, and 798 (16.7%) patients had sentinel lymph node metastases. On multivariable analysis, male sex, truncal tumors, and decreasing thickness were significantly associated with regression (P < .05), whereas head/neck or leg tumors had lower rates of regression (P < .05). Regression was significantly correlated with a decreased risk of sentinel lymph node disease on multivariable analysis (odds ratio 0.68, 95% confidence interval 0.54-0.85; P = .0008). Multivariable analysis also showed that increasing age, male sex, increasing thickness, ulceration, lymphovascular invasion, microsatellitosis, and sentinel lymph node metastasis were significantly (P < .05) associated with worse melanoma-specific survival, while regression was significantly associated with better melanoma-specific survival (hazard ratio 0.75, 95% confidence interval 0.57-0.99; P = .043)., Conclusion: This large study shows that regression is significantly associated with better outcomes in patients with melanoma and is correlated with a lower risk of sentinel lymph node metastasis and a better melanoma-specific survival., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Published
2021
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46. Active surveillance of patients who have sentinel node positive melanoma: An international, multi-institution evaluation of adoption and early outcomes after the Multicenter Selective Lymphadenectomy Trial II (MSLT-2).

Author

Broman KK, Hughes T, Dossett L, Sun J, Kirichenko D, Carr MJ, Sharma A, Bartlett EK, Nijhuis AAG, Thompson JF, Hieken TJ, Kottschade L, Downs J, Gyorki DE, Stahlie E, van Akkooi A, Ollila DW, Frank J, Song Y, Karakousis G, Moncrieff M, Nobes J, Vetto J, Han D, Farma JM, Deneve JL, Fleming MD, Perez MC, Lowe MC, Olofsson Bagge R, Mattsson J, Lee AY, Berman RS, Chai H, Kroon HM, Teras J, Teras RM, Farrow NE, Beasley G, Hui JYC, Been L, Kruijff S, Kim Y, Naqvi SMH, Sarnaik AA, Sondak VK, and Zager JS

Subjects
Adult, Humans, Lymph Node Excision, Neoplasm Recurrence, Local pathology, Retrospective Studies, Sentinel Lymph Node Biopsy, Watchful Waiting, Melanoma pathology, Melanoma surgery, Sentinel Lymph Node pathology, Skin Neoplasms surgery
Abstract

Background: For patients with sentinel lymph node (SLN)-positive cutaneous melanoma, the Second Multicenter Selective Lymphadenectomy trial demonstrated equivalent disease-specific survival (DSS) with active surveillance using nodal ultrasound versus completion lymph node dissection (CLND). Adoption and outcomes of active surveillance in clinical practice and in adjuvant therapy recipients are unknown., Methods: In a retrospective cohort of SLN-positive adults treated at 21 institutions in Australia, Europe, and the United States from June 2017 to November 2019, the authors evaluated the impact of active surveillance and adjuvant therapy on all-site recurrence-free survival (RFS), isolated nodal RFS, distant metastasis-free survival (DMFS), and DSS using Kaplan-Meier curves and Cox proportional hazard models., Results: Among 6347 SLN biopsies, 1154 (18%) were positive and had initial negative distant staging. In total, 965 patients (84%) received active surveillance, 189 (16%) underwent CLND. Four hundred thirty-nine patients received adjuvant therapy (surveillance, 38%; CLND, 39%), with the majority (83%) receiving anti-PD-1 immunotherapy. After a median follow-up of 11 months, 220 patients developed recurrent disease (surveillance, 19%; CLND, 22%), and 24 died of melanoma (surveillance, 2%; CLND, 4%). Sixty-eight patients had an isolated nodal recurrence (surveillance, 6%; CLND, 4%). In patients who received adjuvant treatment without undergoing prior CLND, all isolated nodal recurrences were resectable. On risk-adjusted multivariable analyses, CLND was associated with improved isolated nodal RFS (hazard ratio [HR], 0.36; 95% CI, 0.15-0.88), but not all-site RFS (HR, 0.68; 95% CI, 0.45-1.02). Adjuvant therapy improved all-site RFS (HR, 0.52; 95% CI, 0.47-0.57). DSS and DMFS did not differ by nodal management or adjuvant treatment., Conclusions: Active surveillance has been adopted for most SLN-positive patients. At initial assessment, real-world outcomes align with randomized trial findings, including in adjuvant therapy recipients., Lay Summary: For patients with melanoma of the skin and microscopic spread to lymph nodes, monitoring with ultrasound is an alternative to surgically removing the remaining lymph nodes. The authors studied adoption and real-world outcomes of ultrasound monitoring in over 1000 patients treated at 21 centers worldwide, finding that most patients now have ultrasounds instead of surgery. Although slightly more patients have cancer return in the lymph nodes with this strategy, typically, it can be removed with delayed surgery. Compared with up-front surgery, ultrasound monitoring results in the same overall risk of melanoma coming back at any location or of dying from melanoma., (© 2021 American Cancer Society.)

Published
2021
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47. What is the Cost-Effective Treatment for Melanoma Patients with a Positive Sentinel Node?

Author

Standage H, Hersh AR, Caughey A, Taylor M, Vetto J, and Han D

Subjects
Cost-Benefit Analysis, Humans, Lymph Node Excision, Lymphatic Metastasis, Neoplasm Recurrence, Local drug therapy, Sentinel Lymph Node Biopsy, Melanoma drug therapy, Melanoma surgery, Sentinel Lymph Node surgery, Skin Neoplasms drug therapy, Skin Neoplasms surgery
Abstract

Background: Survival for positive sentinel lymph node (SLN) patients does not differ between completion lymph node dissection (CLND) and nodal observation (OBS). However, treating these patients with CLND and checkpoint inhibitors, such as pembrolizumab (PEM), improves outcomes. This study evaluated the cost-effectiveness of OBS, CLND, and CLND with PEM (CLND-PEM) treatments., Methods: A Markov model was designed to simulate treatment for a theoretical cohort of 1000 positive SLN patients per therapy with a 5-year follow-up period. An intervention was cost-effective if its incremental cost-effectiveness ratio among therapies was below the willingness-to-pay threshold of $100,000 per quality-adjusted life year (QALY)., Results: Compared with CLND or CLND-PEM, OBS resulted in fewer lymphedema cases but in more disease recurrences. Compared with OBS, CLND had higher costs and lower QALYs. Although CLND-PEM had a lower number of recurrences and deaths than OBS or CLND, it had higher costs and lower QALYs than OBS, and thus was not cost-effective. However, with the effects of CLND from CLND-PEM removed, allowing evaluation of PEM effects alone (PEM alone), the resulting QALYs were the highest, but PEM alone still was not cost-effective compared with OBS ($1.2 million per QALY). By reducing the drug cost to less than $14,404 per patient, PEM alone would become cost-effective., Conclusions: Compared with CLND, CLND-PEM, and PEM alone, OBS was cost-effective for managing positive SLN patients. Although CLND-PEM and PEM alone result in fewer recurrences and deaths, these therapies were not cost-effective due to the quality-of-life decrement of CLND and the current high drug cost of PEM.

Published
2021
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48. Surveillance of Sentinel Node-Positive Melanoma Patients with Reasons for Exclusion from MSLT-II: Multi-Institutional Propensity Score Matched Analysis.

Author

Broman KK, Hughes TM, Dossett LA, Sun J, Carr MJ, Kirichenko DA, Sharma A, Bartlett EK, Nijhuis AA, Thompson JF, Hieken TJ, Kottschade L, Downs J, Gyorki DE, Stahlie E, van Akkooi A, Ollila DW, Frank J, Song Y, Karakousis G, Moncrieff M, Nobes J, Vetto J, Han D, Farma J, Deneve JL, Fleming MD, Perez M, Baecher K, Lowe M, Bagge RO, Mattsson J, Lee AY, Berman RS, Chai H, Kroon HM, Teras RM, Teras J, Farrow NE, Beasley GM, Hui JY, Been L, Kruijff S, Boulware D, Sarnaik AA, Sondak VK, and Zager JS

Subjects
Adult, Aged, Chemotherapy, Adjuvant statistics & numerical data, Clinical Trials, Phase III as Topic, Follow-Up Studies, Humans, Lymph Node Excision standards, Lymph Node Excision statistics & numerical data, Lymphatic Metastasis therapy, Male, Melanoma diagnosis, Melanoma mortality, Melanoma pathology, Middle Aged, Multicenter Studies as Topic, Neoplasm Staging, Patient Selection, Prognosis, Propensity Score, Radiotherapy, Adjuvant statistics & numerical data, Randomized Controlled Trials as Topic, Sentinel Lymph Node pathology, Sentinel Lymph Node Biopsy statistics & numerical data, Skin Neoplasms mortality, Skin Neoplasms pathology, Watchful Waiting standards, Lymphatic Metastasis diagnosis, Melanoma therapy, Neoplasm Recurrence, Local epidemiology, Skin Neoplasms therapy, Watchful Waiting statistics & numerical data
Abstract

Background: In sentinel lymph node (SLN)-positive melanoma, two randomized trials demonstrated equivalent melanoma-specific survival with nodal surveillance vs completion lymph node dissection (CLND). Patients with microsatellites, extranodal extension (ENE) in the SLN, or >3 positive SLNs constitute a high-risk group largely excluded from the randomized trials, for whom appropriate management remains unknown., Study Design: SLN-positive patients with any of the three high-risk features were identified from an international cohort. CLND patients were matched 1:1 with surveillance patients using propensity scores. Risk of any-site recurrence, SLN-basin-only recurrence, and melanoma-specific mortality were compared., Results: Among 1,154 SLN-positive patients, 166 had ENE, microsatellites, and/or >3 positive SLN. At 18.5 months median follow-up, 49% had recurrence (vs 26% in patients without high-risk features, p < 0.01). Among high-risk patients, 52 (31%) underwent CLND and 114 (69%) received surveillance. Fifty-one CLND patients were matched to 51 surveillance patients. The matched cohort was balanced on tumor, nodal, and adjuvant treatment factors. There were no significant differences in any-site recurrence (CLND 49%, surveillance 45%, p = 0.99), SLN-basin-only recurrence (CLND 6%, surveillance 14%, p = 0.20), or melanoma-specific mortality (CLND 14%, surveillance 12%, p = 0.86)., Conclusions: SLN-positive patients with microsatellites, ENE, or >3 positive SLN constitute a high-risk group with a 2-fold greater recurrence risk. For those managed with nodal surveillance, SLN-basin recurrences were more frequent, but all-site recurrence and melanoma-specific mortality were comparable to patients treated with CLND. Most recurrences were outside the SLN-basin, supporting use of nodal surveillance for SLN-positive patients with microsatellites, ENE, and/or >3 positive SLN., (Crown Copyright © 2020. Published by Elsevier Inc. All rights reserved.)

Published
2021
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49. Sentinel Lymph Node Biopsy Is Prognostic in Thickest Melanoma Cases and Should Be Performed for Thick Melanomas.

Author

Han D, Han G, Duque MT, Morrison S, Leong SP, Kashani-Sabet M, Vetto J, White R, Schneebaum S, Pockaj B, Mozzillo N, Sondak VK, and Zager JS

Subjects
Humans, Male, Prognosis, Retrospective Studies, Sentinel Lymph Node Biopsy, Melanoma surgery, Sentinel Lymph Node surgery, Skin Neoplasms surgery
Abstract

Background: Sentinel lymph node biopsy (SLNB) is recommended for intermediate thickness melanoma, but for thick melanoma, guidelines are less definitive about the use of SLNB in this population. We present a study on thick melanoma evaluating for prognostic factors., Patients and Methods: The Sentinel Lymph Node Working Group database was queried for thick (> 4 mm) melanoma cases that had a SLNB from 1993 to 2018. Clinicopathologic characteristics were correlated with SLN status and melanoma-specific survival (MSS)., Results: There were 1235 patients. Median follow-up was 28 months. Median thickness was 5.9 mm, with 956, 175, and 104 cases presenting thickness > 4-8, > 8-12, and > 12 mm, respectively. SLN metastases were seen in 439 of 1235 (35.5%) cases and in 33.9%, 40.6%, and 42.3% of melanomas > 4-8, > 8-12, and > 12 mm, respectively. In each thickness group, MSS was significantly worse for SLN-positive compared with SLN-negative cases (all P < 0.005). Multivariable analysis showed that SLN metastasis, male gender, increasing thickness, lymphovascular invasion, and microsatellitosis significantly predicted worse MSS for melanomas > 4-8 mm, with SLN metastasis showing the greatest risk (HR 2.17, 95% CI 1.64-2.87, P < 0.0001). For melanomas > 8 mm, only SLN metastasis significantly predicted MSS (> 8-12 mm: HR 3.93, 95% CI 2.00-7.73, P < 0.0001; > 12 mm: HR 3.58, 95% CI 1.56-8.22, p < 0.0027)., Conclusions: Thick melanoma patients with SLN metastasis have significantly worse MSS compared with SLN-negative patients, even in the thickest cases, and SLN status is the most powerful and/or only predictor of MSS. Given these results, SLNB shows important prognostic value in this population and is indicated for clinically localized thick melanoma.

Published
2021
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50. Factors predicting survival in thick melanoma: Do all thick melanomas have the same prognosis?

Author

Han D, Han G, Morrison S, Leong SP, Kashani-Sabet M, Vetto J, White R, Schneebaum S, Pockaj B, Mozzillo N, Sondak VK, and Zager JS

Subjects
Aged, Blood Vessels pathology, Disease-Free Survival, Female, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Lymphatic Metastasis pathology, Lymphatic Vessels pathology, Male, Melanoma pathology, Melanoma surgery, Middle Aged, Neoplasm Invasiveness pathology, Neoplasm Recurrence, Local pathology, Prognosis, Retrospective Studies, Sentinel Lymph Node pathology, Sentinel Lymph Node Biopsy statistics & numerical data, Skin Neoplasms pathology, Skin Neoplasms surgery, Tumor Burden, Dermatologic Surgical Procedures, Melanoma mortality, Neoplasm Recurrence, Local epidemiology, Skin pathology, Skin Neoplasms mortality
Abstract

Background: It is unknown whether all thick melanomas share the same prognostic features. We present a large, multi-institutional study on thick melanoma, evaluating for factors prognostic of survival., Methods: We queried the database of the Sentinel Lymph Node Working Group for patients with thick melanoma (>4 mm) who had a sentinel lymph node biopsy from 1993 to 2018. Clinicopathologic characteristics were correlated with overall survival., Results: There were 1,235 patients with a median follow-up of 28 months. Median thickness was 5.9 mm, with 713, 356, and 166 cases having a thickness of >4 to 6, >6 to 10, and >10 mm, respectively. Ulceration was seen in 51.2% of cases, while sentinel lymph node metastases were seen in 439 of 1,235 (35.5%) cases. For melanomas >4 to 6 mm, age, thickness, ulceration, lymphovascular invasion, and sentinel lymph node metastasis were correlated with overall survival (all P < .05), but for melanomas >6 to 10 mm, only sex and sentinel lymph node metastasis were prognostic of overall survival (both P < .05). For melanomas >10 mm, only sentinel lymph node metastasis predicted overall survival on multivariable analyses (P < .05)., Conclusion: Prognostic markers of overall survival for thick melanoma include thickness, ulceration, and sentinel lymph node metastasis, but also include other unique factors such as lymphovascular invasion. Moreover, certain prognostic markers for survival are associated with different subgroups of thick melanoma, which vary based on thickness group., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Published
2020
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