3/8/2014. Case Presentation. Primary Treatment of Anal Cancer. Anatomy. Overview. March 6, 2014

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1 Case Presentation Primary Treatment of Anal Cancer 65 year old female presents with perianal pain, lower GI bleeding, and anemia with Hb of 7. On exam 6 cm mass protruding through the anus with bulky R inguinal lymphadenopathy. What is the work-up and ideal treatment for this patient? Albert J. Chang, M.D., Ph.D. Assistant Professor Radiation Oncology UCSF March 6, 2014 Overview Anatomy Anatomy Evolution of Treatment Future Directions Anal canal is 3-4 cm in length From: Anal verge - Where the walls of the anal canal come into contact To: Anorectal ring Upper border of sphincteric/puborectalis muscle 1

2 Clinical Presentation Staging Workup Presenting Symptoms: Rectal bleeding (45%) Pain or sensation of a mass being present (30%) No tumor related symptoms (20%) Condyloma in homosexual (50%) or heterosexual men/woman (30%) At initial presentation, most patients have a T1/T2 tumor, 20-35% are node positive, and <10% have distant metastatic disease. History/Physical with biopsy of primary tumor, palpation of bilateral groins. Women: GYN exam, with cervical cancer screening Anoscopy, proctoscopy, consider c-scope to r/o other bleeding sources. Basic Labs, HIV screening if risk factors present PET/CT Scan 1) Back to our patient. Bx of perianal mass demonstrates poorly differentiated SCCa The Old Treatment (Prior to 1980s) Abdominoperineal Resection Removal of the anus, rectum, part of sigmoid, and associated lymph nodes, through incisions made in the abdomen and perineum. Results in permanent colostomy n 5y OS Local or Regional Recurrence Hardcastle & Bussey 92 48% 27% Greenall et al % 32% Bowman et al % 34% 2

3 Nigro Regimen Nigro Regimen Preoperative Chemoradiation Therapy (Nigro Regimen) 45 pts treated with Nigro regimen 5-FU/Mitomycin C + 30 Gy radiation therapy Post-tx biopsy 38 pts (84%) without residual disease, none recurred within 5 years 7 pts with residual disease 7/7 progressed c distant mets. Nigro Regimen Further verified by multiple phase II studies Series Wayne State (Leichman) 1 Italian (Doci) 2 France (Peiffert) 3 Patient Population 45 pts c any stage anal CA. 35 pts c untreated epidermoid anal cancer 30 pts c anal CA >4cm or c (+) nodes. Treatment Regimen Nigro regimen post tx biopsy APR at discretion of MD. Concurrent cisplatin/5fu chemort (36-38 Gy) followed by RT boost (18-24 Gy), post tx biopsy. Chemo chemort (cisplatin/5fu). RT was to pelvis/inguinal to 30 or 45 Gy, followed by Gy boost p 6 wks RTOG pts c any stage anal Ca. Nigro regimen chemo, RT to 40.8 Gy in 4.5-5wks. Outcome Reported 38/45 pcr, none recurred at 5 years. CR in 94%. At median f/u 37 months, 94% of pts NED, 86% colostomy free. ppr/cr was 11%/61% after chemo, 59%/31% after chemort, 96%/0% at COT. OS 1 year, 3 years. Questions Raised Is chemotherapy a necessary component of definitive treatment? Is the Nigro regimen an ideal chemotherapy regimen? Toxicity of mito-c Phase II data looked promising for use of CDDP. 1) Leichman et al. Cancer of the anal canal. Model for preoperative adjuvant combined modality therapy. Am J Med 1985 Feb; 78(2): ) Doci et al. Primary chemoradiation therapy with fluorouracil and cisplatin for cancer of the anus: results in 35 consecutive patients. JCO 14(12): ) Peiffert et al. Preliminary results of a phase II study of high dose radiation therapy and neoadjuvant plus concomitant 5-FU with CDDP chemotherapy for pts with anal Cancer: a French cooperative study. Annals of Oncology 8(6): ) Sischy et al. Definitive irradiation and chemotherapy for radiosensitization in management of anal carcinoma: interim report on RTOG J. of the NCI. 81(11):

4 Questions Raised Is chemotherapy a necessary component of definitive treatment? Is the Nigro regimen an ideal chemotherapy regimen? Toxicity of mito-c Phase II data looked promising for use of CDDP. RT vs. Chemo RT? UKCCR (ACT I) 585 pts c anal CA, everyone except T1N0 Randomize to: Arm A: RT alone (45 Gy) Arm B: ChemoRT (Nigro regimen) Assess Clinical response 6 weeks after treatment >50% response additional RT <50% response APR Lancet 1996 Oct 19;348(9034): UKCCR (ACT I) - RESULTS UKCCCR (ACT I) Major Findings in 13 Yr Update Chemoradiation therapy associated with: 46% decreased in local failure (p <0.001) 29% reduction in anal cancer death (HR 0.71, p=0.02) No difference in OS Increased acute toxicity with chemotherapy No change in late toxicity Lancet 1996 Oct 19;348(9034): British Journal of Cancer (2010) 102,

5 Questions Raised Questions Raised Is chemotherapy a necessary component of definitive treatment? YES Is the Nigro regimen an ideal chemotherapy regimen? Toxicity of mito-c Phase II data looked promising for use of CDDP. Is chemotherapy a necessary component of definitive treatment? YES Is the Nigro regimen an ideal chemotherapy regimen? Toxicity of mito-c Phase II data looked promising for use of CDDP. RTOG 8704 RTOG 8704 Does mitomycin C have to be included in the Nigro regimen? Mitomycin C was not typically considered a radiosensitizer, and was thought to have only modest activity against SCC. Significant heme toxicity, i.e. thrombocytopenia J Clin Oncol 1996 Sep;14(9): Arms N 5y LR 5y CFS 5y DFS 5FU + RT 5FU/MMC + RT 1) J Clin Oncol 1996 Sep;14(9): % 58% 50% % (p<0.001) 64% (p=0.09) 67% (p<0.003) 1) Size important prognostic factor: -Post-treatment biopsy (6 wks): 93% negative if <5 cm, 83% negative if >5 cm -7/22 patients with + biopsies successfully salvaged with additional RT 2) Greater toxicity with MMC -Grade 4 toxicity: 23% vs. 7% -Grade 5 toxicity: 2.7% vs. 0.7% 5

6 Can cisplatin replace mitomycin C? RTOG FU/Mitomycin 2 cycles RTOG 9811 Disease Free Survival 100 R Stratifications a Gender n Clinical N d T size o m i z e Radiation therapy 45 to 59 Gy 5-FU/Cisplatin 2 cycles Primary Endpoint = DFS n = FU/Cisplatin 2 cycles Radiation therapy 45 to 59 Gy Disease-Free Survival (%) Patients at Risk RT+5FU/MMC RT+5FU/CDDP FailedTotal RT+5FU/MMC log-rank p-value = RT+5FU/CDDP HR = 1.39 (1.10, 1.76) Years after Randomization ) JAMA Apr 23;299(16): RTOG 9811 Overall Survival RTOG 9811 Multivariate Analysis for DFS Overall Survival (%) Patients at Risk RT+5FU/MMC RT+5FU/CDDP FailedTotal RT+5FU/MMC log-rank p-value = RT+5FU/CDDP HR = 1.37 (1.04, 1.81) Years after Randomization y OS 78.3% vs. 70.7% p= Adjustment variable Treatment Gender Primary Size Clinical Node Status *Cox proportional hazards model Comparison 5FU/MMC vs. 5FU/CDDP Female vs. Male >2-5 cm vs. >5 cm Negative vs. Positive Adjusted HR (95% CI) p-value* 1.40 ( ) 1.29 ( ) 1.56 ( ) 1.80 ( ) <

7 Critique of RTOG 9811 ACT II R Stratifications a Gender n Clinical N d T size o m i z e 5-FU/Mitomycin 2 cycles Radiation therapy 45 to 59 Gy 5-FU/Cisplatin 2 cycles 5-FU/Cisplatin 2 cycles Radiation therapy 45 to 59 Gy Primary Endpoint = DFS n = 650 *Trial may have actually tested timing of RT -induction chemo vs. immediate definitive chemort 1) JAMA Apr 23;299(16): ACT II ACT II MMC vs. Cisplatin MMC vs. Cisplatin Maintenance Chemo? 7

8 Site of Initial Recurrence ACT II: Results MMC N=472 CDDP N=468 No maintenance N=446 Maintenanc e N=448 Local 4% 6% 5% 5% Loco-regional 4% 5% 5% 4% Loco-regional and Distant 3y PFS 3% 2% 2% 3% % for 5 cm % for <5 cm Non- Hematologic ACT II: Toxicity Data Mitomycin C Cisplatin Grade 3 Grade 4 Grade 3 Grade 4 53% 10% 58% 10% -GI 19% 1% 27% 1% -Skin 41% 7% 43% 4% -Pain 24% 2% 26% 3% Hematologic 23% 4% 13% 3% Any 63% 13% 63% 12% Questions Raised Is chemotherapy a necessary component of definitive treatment? YES Is the Nigro regimen an ideal chemotherapy regimen? Either 5FU/MMC or 5FU/Cisplatin Conclusion Current standard of care for anal SCC is definitive chemoradiation with APR as salvage Either 5FU/MMC or 5FU/Cisplatin is acceptable with similar outcomes 5FU/cisplatin may have less hematologic toxicity With current treatments, high rate of acute Grade 3 or 4 toxicity up to 60-70% Tumors 5 cm have high failure rate 8

9 Follow - Up Physical exam, including DRE 8-12 weeks after COT. Biopsy ONLY if clinical evidence of persistent disease after serial exams. Future Directions Radiation methods to reduce toxicity Dose painting with intensity modulated radiotherapy Radiation methods to decrease local failure rate in patients with large >5 cm tumors Brachytherapy APR for salvage if persistant disease DRE, anoscopy, inguinal node palpation Q3-6months x 5 years. Historical RT Technique Intensity Modulated Radiation Therapy 9

10 RTOG 0529 Results Potential Solution to Decrease Local Failure.. Brachytherapy? Happy Ending! Thank You! Pre-Treatment Post-Treatment 10

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