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

Eroglu, Zeynep; Broman, Kristy K; Thompson, John F; Nijhuis, Amanda; Hieken, Tina J; Kottschade, Lisa; Farma, Jeffrey M; Hotz, Meghan; Deneve, Jeremiah; Fleming, Martin; Bartlett, Edmund K; Sharma, Avinash; Dossett, Lesly; Hughes, Tasha; Gyorki, David E; Downs, Jennifer; Karakousis, Giorgos; Song, Yun; Lee, Ann; Berman, Russell S; van Akkooi, Alexander; Stahlie, Emma; Han, Dale; Vetto, John; Beasley, Georgia; Farrow, Norma E; Hui, Jane Yuet Ching; Moncrieff, Marc; Nobes, Jenny; Baecher, Kirsten; Perez, Matthew; Lowe, Michael; Ollila, David W; Collichio, Frances A; Bagge, Roger Olofsson; Mattsson, Jan; Kroon, Hidde M; Chai, Harvey; Teras, Jyri; Sun, James; Carr, Michael J; Tandon, Ankita; Babacan, Nalan Akgul; Kim, Younchul; Naqvi, Mahrukh; Zager, Jonathan; Khushalani, Nikhil I
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.
PMCID:9413295
PMID: 36002183
ISSN: 2051-1426
CID: 5374652

Outcomes After Surgical Palliation of Patients With Gastric Cancer

Nohria, Ambika; Kaslow, Sarah R; Hani, Leena; He, Yanjie; Sacks, Greg D; Berman, Russell S; Lee, Ann Y; Correa-Gallego, Camilo
INTRODUCTION/BACKGROUND:Surgery is an option for symptom palliation in patients with metastatic gastric cancer. Operative outcomes after palliative interventions are largely unknown. Herein, we assess the trends of surgical palliation use for patients with gastric cancer and describe outcomes of patients undergoing surgical palliation compared to nonsurgical palliation. METHODS:Patients with clinical Stage IV gastric cancer in the National Cancer Database (2004-2015) who received surgical or nonsurgical palliation were selected. We identified factors associated with palliative surgery. Survival differences were assessed by Kaplan-Meier estimate, Cox proportional hazard regression, and log rank test. RESULTS:Six thousand eight hundred twenty nine patients received palliative care for gastric cancer. Most patients (87%, n = 5944) received nonsurgical palliation: 29% radiation therapy, 57% systemic treatment, and 14% pain management. The number of patients receiving palliative care increased between 2004 and 2015; however, use of surgical palliation declined significantly (22% in 2004, 8% in 2015; P < 0.001). Median overall survival (OS) for the cohort was 5.65 mo (95% confidence interval 5.45-5.85); 1-year and 2-year OS were 24% and 9%, respectively. Older age at diagnosis and diagnosis between 2004 and 2006 were significantly associated with undergoing surgical palliation. Patients who underwent surgical palliation had significantly shorter median OS and a 20% higher hazard of mortality than those who received nonsurgical palliation. CONCLUSIONS:Patients with metastatic gastric cancer experience very short survival. While palliative surgery is used infrequently, the observed association with shorter median OS underscores the importance of careful patient selection. Palliative surgery should be offered judiciously and expectations about outcomes clearly established.
PMID: 35809355
ISSN: 1095-8673
CID: 5280742

Systemic therapy for duodenal adenocarcinoma: An analysis of the National Cancer Database (NCDB)

Kaslow, Sarah R; Prendergast, Katherine; Vitiello, Gerardo A; Hani, Leena; Berman, Russell S; Lee, Ann Y; Correa-Gallego, Camilo
BACKGROUND:National Comprehensive Cancer Network guidelines recommend resection and adjuvant chemotherapy for patients with locally advanced duodenal adenocarcinoma. Outcomes after systemic treatment in this rare malignancy have not been well studied. We examined utilization patterns of systemic treatment and compared overall survival of patients receiving neoadjuvant therapy, surgery alone, and adjuvant therapy. METHODS:Patients with stage 0 to III duodenal adenocarcinoma undergoing curative-intent surgery were identified within the National Cancer Database from 2006 to 2015. Outcomes, including median overall survival and 30- and 90-day mortality, were compared based on treatment sequence (neoadjuvant, adjuvant, or surgery alone). Propensity score matching on likelihood of receiving systemic treatment and landmark analysis were performed to mitigate bias. RESULTS:Of the 2,956 patients meeting inclusion criteria, most patients with known clinical stage had locally advanced disease (72%), of which 53% received systemic therapy (8% neoadjuvant, 45% adjuvant). After landmark analysis on the propensity matched cohort, patients with locally advanced disease who received systemic treatment had longer median overall survival compared to patients who underwent surgery alone (49 vs 40 months, P = .018) and a 20% lower hazard of mortality (hazard ratio 0.80, 95% confidence interval 0.69-0.93, P = .003). Patients who received neoadjuvant and adjuvant therapy had similar survival outcomes. CONCLUSION/CONCLUSIONS:Adjuvant therapy was underutilized in patients with National Comprehensive Cancer Network guideline indications, despite an association with longer median overall survival and decreased hazard of mortality. Neoadjuvant therapy, although rarely used, had similar survival to adjuvant therapy. Given its other potential benefits, systemic treatment in the neoadjuvant setting may be a reasonable option in adequately selected patients with clinically advanced duodenal adenocarcinoma.
PMID: 35437164
ISSN: 1532-7361
CID: 5218192

The efficacy of immune checkpoint blockade for melanoma in-transit with or without nodal metastases - A multicenter cohort study

Holmberg, Carl-Jacob; Ny, Lars; Hieken, Tina J; Block, Matthew S; Carr, Michael J; Sondak, Vernon K; Örtenwall, Christoffer; Katsarelias, Dimitrios; Dimitriou, Florentia; Menzies, Alexander M; Saw, Robyn Pm; Rogiers, Aljosja; Straker, Richard J; Karakousis, Giorgos; Applewaite, Rona; Pallan, Lalit; Han, Dale; Vetto, John T; Gyorki, David E; Tie, Emilia Nan; Vitale, Maria Grazia; Ascierto, Paulo A; Dummer, Reinhard; Cohen, Jade; Hui, Jane Yc; Schachter, Jacob; Asher, Nethanel; Helgadottir, H; Chai, Harvey; Kroon, Hidde; Coventry, Brendon; Rothermel, Luke D; Sun, James; Carlino, Matteo S; Duncan, Zoey; Broman, Kristy; Weber, Jeffrey; Lee, Ann Y; Berman, Russell S; Teras, Jüri; Ollila, David W; Long, Georgina V; Zager, Jonathan S; van Akkooi, Alexander; Olofsson Bagge, Roger
PURPOSE/OBJECTIVE:Guidelines addressing melanoma in-transit metastasis (ITM) recommend immune checkpoint inhibitors (ICI) as a first-line treatment option, despite the fact that there are no efficacy data available from prospective trials for exclusively ITM disease. The study aims to analyze the outcome of patients with ITM treated with ICI based on data from a large cohort of patients treated at international referral clinics. METHODS:A multicenter retrospective cohort study of patients treated between January 2015 and December 2020 from Australia, Europe, and the USA, evaluating treatment with ICI for ITM with or without nodal involvement (AJCC8 N1c, N2c, and N3c) and without distant disease (M0). Treatment was with PD-1 inhibitor (nivolumab or pembrolizumab) and/or CTLA-4 inhibitor (ipilimumab). The response was evaluated according to the RECIST criteria modified for cutaneous lesions. RESULTS:A total of 287 patients from 21 institutions in eight countries were included. Immunotherapy was first-line treatment in 64 (22%) patients. PD-1 or CTLA-4 inhibitor monotherapy was given in 233 (81%) and 23 (8%) patients, respectively, while 31 (11%) received both in combination. The overall response rate was 56%, complete response (CR) rate was 36%, and progressive disease (PD) rate was 32%. Median PFS was ten months (95% CI 7.4-12.6 months) with a one-, two-, and five-year PFS rate of 48%, 33%, and 18%, respectively. Median MSS was not reached, and the one-, two-, and five-year MSS rates were 95%, 83%, and 71%, respectively. CONCLUSION/CONCLUSIONS:Systemic immunotherapy is an effective treatment for melanoma ITM. Future studies should evaluate the role of systemic immunotherapy in the context of multimodality therapy, including locoregional treatments such as surgery, intralesional therapy, and regional therapies.
PMID: 35644725
ISSN: 1879-0852
CID: 5236022

Surgical Treatment of Patients with Poorly Differentiated Pancreatic Neuroendocrine Carcinoma: An NCDB Analysis

Kaslow, Sarah R; Vitiello, Gerardo A; Prendergast, Katherine; Hani, Leena; Cohen, Steven M; Wolfgang, Christopher; Berman, Russell S; Lee, Ann Y; Correa-Gallego, Camilo
BACKGROUND:Consensus guidelines discourage resection of poorly differentiated pancreatic neuroendocrine carcinoma (panNEC) given its association with poor long-term survival. This study assessed treatment patterns and outcomes for this rare malignancy using the National Cancer Database (NCDB). METHODS:Patients with non-functional pancreatic neuroendocrine tumors in the NCDB (2004-2016) were categorized based on pathologic differentiation. Logistic and Cox proportional hazard regressions identified associations with resection and overall survival (OS). Survival was compared using Kaplan-Meier and log-rank tests. RESULTS:Most patients (83%) in the cohort of 8560 patients had well-differentiated tumors (panNET). The median OS was 47 months (panNET, 63 months vs panNEC, 17 months; p < 0.001). Surgery was less likely for older patients (odds ratio [OR], 0.97), patients with panNEC (OR, 0.27), and patients with metastasis at diagnosis (OR, 0.08) (all p < 0.001). After propensity score-matching of these factors, surgical resection was associated with longer OS (82 vs 29 months; p < 0.001) and a decreased hazard of mortality (hazard ratio [HR], 0.37; p < 0.001). Surgery remained associated with longer OS when stratified by differentiation (98 vs 41 months for patients with panNET and 36 vs 8 months for patients with panNEC). Overall survival did not differ between patients with panNEC who underwent surgery and patients with panNET who did not (both 39 months; p = 0.294). CONCLUSIONS:Poorly differentiated panNEC exhibits poorer survival than well-differentiated panNET. In the current cohort, surgical resection was strongly and independently associated with improved OS, suggesting that patients with panNEC who are suitable operative candidates should be considered for multimodality therapy, including surgery.
PMID: 35246811
ISSN: 1534-4681
CID: 5173682

ASO Visual Abstract: Surgical Treatment of Patients with Poorly Differentiated Pancreatic Neuroendocrine Carcinoma-An NCDB Analysis

Kaslow, Sarah R; Vitiello, Gerardo A; Prendergast, Katherine; Hani, Leena; Cohen, Steven M; Wolfgang, Christopher; Berman, Russell S; Lee, Ann Y; Correa-Gallego, Camilo
PMID: 35249164
ISSN: 1534-4681
CID: 5173692

The Importance of Studying Our Surveillance Strategies [Editorial]

Lee, Ann Y
PMID: 35089450
ISSN: 1534-4681
CID: 5154872

Correction to: The Devil's in the Details: Discrepancy Between Biopsy Thickness and Final Pathology in Acral Melanoma

Lee, Ann Y; Friedman, Erica B; Sun, James; Potdar, Aishwarya; Daou, Hala; Farrow, Norma E; Farley, Clara R; Vetto, John T; Han, Dale; Tariq, Marvi; Shapiro, Richard; Beasley, Georgia; Contreras, Carlo M; Osman, Iman; Lowe, Michael; Zager, Jonathan S; Berman, Russell S
PMID: 33893602
ISSN: 1534-4681
CID: 4889162

Attrition during neoadjuvant chemotherapy for gastric adenocarcinoma is associated with decreased survival: A United States Safety-Net Collaborative analysis

Kronenfeld, Joshua P; Collier, Amber L; Turgeon, Michael K; Ju, Michelle; Alterio, Rodrigo; Wang, Annie; Fernandez, Manuel; Porembka, Matthew R; Richter, Harry; Lee, Ann Y; Russell, Maria C; Merchant, Nipun B; Maker, Ajay V; Datta, Jashodeep
BACKGROUND:Neoadjuvant chemotherapy (NAC) is standard management for localized gastric cancer (GC). Attrition during NAC due to treatment-related toxicity or functional decline is considered a surrogate for worse biologic outcomes; however, data supporting this paradigm are lacking. We investigated factors predicting attrition and its association with overall survival (OS) in GC. METHODS:Patients with nonmetastatic GC initiating NAC were identified from the US Safety-Net Collaborative (2012-2014). Patient/treatment-related characteristics were compared between attrition/nonattrition cohorts. Cox models determined factors associated with OS. RESULTS:Of 116 patients initiating NAC, attrition during prescribed NAC occurred in 24%. No differences were observed in performance status, comorbidities, treatment at safety-net hospital, or clinicopathologic factors between cohorts. Despite absence of distinguishing factors, attrition was associated with worse OS (median: 11 vs. 37 months; p = 0.01) and was an independent predictor of mortality (hazard ratio [HR]: 4.7, 95% confidence interval [CI]: 1.5-15.2; p = 0.02). Fewer patients with attrition underwent curative-intent surgery (39% vs. 89%; p < 0.001). Even in patients undergoing surgical exploration (n = 89), NAC attrition remained an independent predictor of worse OS (HR: 50.8, 95% CI: 3.6-717.8; p = 0.004) despite similar receipt of adjuvant chemotherapy. CONCLUSION/CONCLUSIONS:Attrition during NAC for nonmetastatic GC is independently associated with worse OS, even in patients undergoing surgery. Attrition during NAC may reflect unfavorable tumor biology not captured by conventional staging metrics.
PMID: 34379324
ISSN: 1096-9098
CID: 5006212

Is there a difference in utilization of a perioperative treatment approach for gastric cancer between safety net hospitals and tertiary referral centers?

Turgeon, Michael K; Lee, Rachel M; Keilson, Jessica M; Ju, Michelle R; Porembka, Matthew R; Alterio, Rodrigo E; Kronenfeld, Joshua; Datta, Jashodeep; Goel, Neha; Wang, Annie; Lee, Ann Y; Fernandez, Manuel; Richter, Harry; Maker, Ajay V; Maithel, Shishir K; Russell, Maria C
BACKGROUND AND OBJECTIVES/OBJECTIVE:Perioperative therapy is a favored treatment strategy for gastric cancer. We sought to assess utilization of this approach at safety net hospitals (SNH) and tertiary referral centers (TRC). MATERIALS AND METHODS/METHODS:Patients in the US Safety Net Collaborative (2012-2014) with resectable gastric cancer across five SNH and their sister TRC were included. Primary outcomes were receipt of neoadjuvant chemotherapy (NAC) and perioperative therapy. RESULTS:Of 284 patients, 36% and 64% received care at SNH and TRC. The distribution of Stage II/III resectable disease was similar across facilities. Receipt of NAC at SNH and TRC was similar (56% vs. 46%, p = 0.27). Compared with overall clinical stage, 38% and 36% were pathologically downstaged at SNH and TRC, respectively. Among patients who received NAC, those who also received adjuvant chemotherapy at SNH and TRC were similar (66% vs. 60%, p = 0.50). Asian race and higher clinical stage were associated with receipt of perioperative therapy (both p < 0.05) while treatment facility type was not. CONCLUSIONS:There was no difference in utilization of a perioperative treatment strategy between facility types for patients with gastric cancer. Pathologic downstaging from NAC was similar across treatment facilities, suggesting similar quality and duration of therapy. Treatment at an SNH is not a barrier to receiving standard-of-care perioperative therapy for gastric cancer.
PMID: 34061369
ISSN: 1096-9098
CID: 4895372