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Affiliations
1 The University of Texas-MD Anderson Cancer Center, Houston, TX, USA.
2 Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.
3 Northwestern University, Chicago, IL, USA.
4 University of Southern California, Los Angeles, CA, USA.
5 Washington University, St Louis, MO, USA.
6 The Ohio State University, Columbus, OH, USA.
7 University of Chicago, Chicago, IL, USA.
8 University of Wisconsin, Madison, WI, USA.
9 Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.
10 Decatur Memorial Hospital, Decatur, IL, USA.
11 Guardant Health, Redwood City, CA, USA.
12 National Cancer Institute, Bethesda, MD, USA.
13 The University of Texas-MD Anderson Cancer Center, Houston, TX, USA. Electronic address: ceng@mdanderson.org.
Van K Morris et al. Lancet Oncol. 2017 Apr.
Affiliations
1 The University of Texas-MD Anderson Cancer Center, Houston, TX, USA.
2 Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.
3 Northwestern University, Chicago, IL, USA.
4 University of Southern California, Los Angeles, CA, USA.
5 Washington University, St Louis, MO, USA.
6 The Ohio State University, Columbus, OH, USA.
7 University of Chicago, Chicago, IL, USA.
8 University of Wisconsin, Madison, WI, USA.
9 Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.
10 Decatur Memorial Hospital, Decatur, IL, USA.
11 Guardant Health, Redwood City, CA, USA.
12 National Cancer Institute, Bethesda, MD, USA.
13 The University of Texas-MD Anderson Cancer Center, Houston, TX, USA. Electronic address: ceng@mdanderson.org.
Background: Squamous cell carcinoma of the anal canal (SCCA) is a rare malignancy associated with infection by human papillomavirus (HPV). No consensus treatment approach exists for the treatment of metastatic disease. Because intratumoral HPV oncoproteins upregulate immune checkpoint proteins such as PD-1 to evade immune-mediated cytotoxicity, we did a trial of the anti-PD-1 antibody nivolumab for patients with metastatic SCCA.
Methods: We did this single-arm, multicentre, phase 2 trial at ten academic centres in the USA. We enrolled patients with treatment-refractory metastatic SCCA, who were given nivolumab every 2 weeks (3 mg/kg). The primary endpoint was response according to Response Evaluation Criteria in Solid Tumors, version 1.1, in the intention-to-treat population. At the time of data cutoff, the study was ongoing, with patients continuing to receive treatment. The study is registered with ClinicalTrials.gov, number NCT02314169.
Results: We screened 39 patients, of whom 37 were enrolled and received at least one dose of nivolumab. Among the 37 patients, nine (24% [95% CI 15-33]) had responses. There were two complete responses and seven partial responses. Grade 3 adverse events were anaemia (n=2), fatigue (n=1), rash (n=1), and hypothyroidism (n=1). No serious adverse events were reported.
Interpretation: To our knowledge, this is the first completed phase 2 trial of immunotherapy for SCCA. Nivolumab is well tolerated and effective as a monotherapy for patients with metastatic SCCA. Immune checkpoint blockade appears to be a promising approach for patients with this orphan disease.
Funding: National Cancer Institute/Cancer Therapy Evaluation Program, the HPV and Anal Cancer Foundation, the E B Anal Cancer Fund, The University of Texas MD Anderson Moon Shots Program, and an anonymous philanthropic donor.
Copyright © 2017 Elsevier Ltd. All rights reserved.
PSi has received fees from Bayer Pharmaceuticals and personal fees from Merrimack Pharma. EC has received grants from National Cancer Institute to her institution, and personal fees for advisory boards from Advaxis, Lilly, Merrimack, Bayer, Taiho, and Amgen. MP has received grants from the National Cancer Institute/Cancer Therapy Evaluation Program. KB has received personal fees from Guardant Health. RL has received personal fees from Guardant Health. JA owns stock in, and has acted as a consultant or on advisory boards for, Jounce, Kite Pharma, Evelo, Constellation, Bristol-Myers Squibb, GlaxoSmithKline, AstraZeneca, Amgen, and Neon. PSh owns stock in, and has acted as a consultant for, Jounce, Kite Pharma, Neon, Bristol-Myers Squibb, GlaskoSmithKline, AstraZeneca, Amgen, Constellation, Evelo. CE has received grants from Daiichi and Keryx, and personal fees from Bayer, Sirtex, Genentech, Roche/Genentech, and Bayer. VKM, MES, HN, SI, KC, BP, DD, JLW, LX, TB-S, LV, JB, AM, WCF, CO, GB, AO, JR, AM, RAW, and HS declare no completing interests.
Figure 1. Tumour response in 34 assessable…
Figure 1. Tumour response in 34 assessable patients
(A) Waterfall plot. (B) Duration of response.…
(A) Waterfall plot. (B) Duration of response. The dotted line represents RECIST 1.1 markers of disease progression. Three patients who received only one dose of nivolumab were not assessed.
Progression-free survival (A) and overall…
Progression-free survival (A) and overall survival (B)
Progression-free survival (A) and overall survival (B)
Figure 3. Immune profiling comparing expression of…
Figure 3. Immune profiling comparing expression of various biomarkers in pretreatment biopsies between responders and…
Assessed by immunohistochemistry (A–D) and flow cytometry (E–H). The bars are means (SDs).
Cascinu S. Cascinu S. Lancet Oncol. 2017 Apr;18(4):415-416. doi: 10.1016/S1470-2045(17)30091-8. Epub 2017 Feb 20. Lancet Oncol. 2017. PMID: 28223061 No abstract available.
Martin D, Rödel C, Fokas E. Martin D, et al. Strahlenther Onkol. 2018 Apr;194(4):356-357. doi: 10.1007/s00066-018-1272-8. Strahlenther Onkol. 2018. PMID: 29392353 German. No abstract available.
Sharma P, Retz M, Siefker-Radtke A, Baron A, Necchi A, Bedke J, Plimack ER, Vaena D, Grimm MO, Bracarda S, Arranz JÁ, Pal S, Ohyama C, Saci A, Qu X, Lambert A, Krishnan S, Azrilevich A, Galsky MD. Sharma P, et al. Lancet Oncol. 2017 Mar;18(3):312-322. doi: 10.1016/S1470-2045(17)30065-7. Epub 2017 Jan 26. Lancet Oncol. 2017. PMID: 28131785 Clinical Trial.
Kim S, François E, André T, Samalin E, Jary M, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouché O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, De La Fouchardiere C, Smith D, Deberne M, Spehner L, Badet N, Adotevi O, Anota A, Meurisse A, Vernerey D, Taieb J, Vendrely V, Buecher B, Borg C. Kim S, et al. Lancet Oncol. 2018 Aug;19(8):1094-1106. doi: 10.1016/S1470-2045(18)30321-8. Epub 2018 Jul 2. Lancet Oncol. 2018. PMID: 30042063 Clinical Trial.
Younes A, Santoro A, Shipp M, Zinzani PL, Timmerman JM, Ansell S, Armand P, Fanale M, Ratanatharathorn V, Kuruvilla J, Cohen JB, Collins G, Savage KJ, Trneny M, Kato K, Farsaci B, Parker SM, Rodig S, Roemer MG, Ligon AH, Engert A. Younes A, et al. Lancet Oncol. 2016 Sep;17(9):1283-94. doi: 10.1016/S1470-2045(16)30167-X. Epub 2016 Jul 20. Lancet Oncol. 2016. PMID: 27451390 Free PMC article. Clinical Trial.
Morris V, Eng C. Morris V, et al. Surg Oncol Clin N Am. 2017 Jan;26(1):133-142. doi: 10.1016/j.soc.2016.07.008. Surg Oncol Clin N Am. 2017. PMID: 27889032 Review.
Goldkuhle M, Dimaki M, Gartlehner G, Monsef I, Dahm P, Glossmann JP, Engert A, von Tresckow B, Skoetz N. Goldkuhle M, et al. Cochrane Database Syst Rev. 2018 Jul 12;7(7):CD012556. doi: 10.1002/14651858.CD012556.pub2. Cochrane Database Syst Rev. 2018. PMID: 30001476 Free PMC article. Review.
Wind KL, Riber L, Havelund BM, Serup-Hansen E, Kronborg C, Fode MM, Jakobsen A, Spindler KG. Wind KL, et al. Cancers (Basel). 2021 Jun 28;13(13):3226. doi: 10.3390/cancers13133226. Cancers (Basel). 2021. PMID: 34203394 Free PMC article.
Zhan L, Feng HF, Liu HQ, Guo LT, Chen C, Yao XL, Sun SR. Zhan L, et al. Front Endocrinol (Lausanne). 2021 Jun 10;12:649863. doi: 10.3389/fendo.2021.649863. eCollection 2021. Front Endocrinol (Lausanne). 2021. PMID: 34177799 Free PMC article.
Hester R, Advani S, Rashid A, Holliday E, Messick C, Das P, You YN, Taniguchi C, Koay EJ, Bednarski B, Rodriguez-Bigas M, Skibber J, Wolff R, Chang GJ, Minsky BD, Foo WC, Rothschild N, Morris VK, Eng C. Hester R, et al. Oncotarget. 2021 May 25;12(11):1037-1045. doi: 10.18632/oncotarget.27959. eCollection 2021 May 25. Oncotarget. 2021. PMID: 34084278 Free PMC article.
Gotfrit J, Goodwin R, Asmis T, Hyde AJ, Alcindor T, Aubin F, Berry S, Bossé D, Brown C, Burkes R, Burnell M, Colwell B, Corbett J, Craswell J, Daaboul N, Doherty M, Fleming DAB, Galvis L, Goel R, Harb M, Jeyakumar A, Jonker D, Kennedy E, Lock M, Mahmud A, McCrea PH, Nair V, Nassabein R, Nessim C, Ramjeesingh R, Raza M, Saliba W, Samimi S, Singh S, Snow S, Tehfé M, Thirlwell M, Valdes M, Welch S, Vickers M. Gotfrit J, et al. Curr Oncol. 2021 May 26;28(3):1988-2006. doi: 10.3390/curroncol28030185. Curr Oncol. 2021. PMID: 34073199 Free PMC article.
de Almeida NAA, Ribeiro CRA, Raposo JV, de Paula VS. de Almeida NAA, et al. Viruses. 2021 May 2;13(5):822. doi: 10.3390/v13050822. Viruses. 2021. PMID: 34063186 Free PMC article. Review.

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