RTOG 0529: a phase 2 evaluation of dose-painted intensity modulated radiation therapy in combination with 5-fluorouracil and mitomycin-C for the reduction of acute morbidity in carcinoma of the anal canal.
Lisa A. Kachnic,Kathryn Winter,Robert J. Myerson,Michael Goodyear,John Willins,Jacqueline Esthappan,Michael G. Haddock,Marvin Rotman,Parag J. Parikh,Howard Safran,Christopher G. Willett +10 more
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Although the primary endpoint was not met, DP-IMRT was associated with significant sparing of acute grade 2+ hematologic and grade 3+ dermatologic and gastrointestinal toxicity, which emphasizes the importance of real-time radiation quality assurance for IMRT trials.Abstract:
Purpose A multi-institutional phase 2 trial assessed the utility of dose-painted intensity modulated radiation therapy (DP-IMRT) in reducing grade 2+ combined acute gastrointestinal and genitourinary adverse events (AEs) of 5-fluorouracil (5FU) and mitomycin-C (MMC) chemoradiation for anal cancer by at least 15% compared with the conventional radiation/5FU/MMC arm from RTOG 9811. Methods and Materials T2-4N0-3M0 anal cancer patients received 5FU and MMC on days 1 and 29 of DP-IMRT, prescribed per stage: T2N0, 42 Gy elective nodal and 50.4 Gy anal tumor planning target volumes (PTVs) in 28 fractions; T3-4N0-3, 45 Gy elective nodal, 50.4 Gy ≤3 cm or 54 Gy >3 cm metastatic nodal and 54 Gy anal tumor PTVs in 30 fractions. The primary endpoint is described above. Planned secondary endpoints assessed all AEs and the investigator's ability to perform DP-IMRT. Results Of 63 accrued patients, 52 were evaluable. Tumor stage included 54% II, 25% IIIA, and 21% IIIB. In primary endpoint analysis, 77% experienced grade 2+ gastrointestinal/genitourinary acute AEs (9811 77%). There was, however, a significant reduction in acute grade 2+ hematologic, 73% (9811 85%, P =.032), grade 3+ gastrointestinal, 21% (9811 36%, P =.0082), and grade 3+ dermatologic AEs 23% (9811 49%, P Conclusions Although the primary endpoint was not met, DP-IMRT was associated with significant sparing of acute grade 2+ hematologic and grade 3+ dermatologic and gastrointestinal toxicity. Although DP-IMRT proved feasible, the high pretreatment planning revision rate emphasizes the importance of real-time radiation quality assurance for IMRT trials.read more
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Clinical practice guidelines in oncology
William J. Gradishar,Benjamin O. Anderson,Ron Balassanian,Sarah L. Blair,Harold J. Burstein,Amy E. Cyr,Anthony D. Elias,William B. Farrar,Andres Forero,Sharon H. Giordano,Matthew P. Goetz,Lori J. Goldstein,Steven J. Isakoff,Janice A. Lyons,P. Kelly Marcom,Ingrid A. Mayer,Beryl McCormick,Meena S. Moran,Ruth O'Regan,Sameer A. Patel,Lori J. Pierce,Elizabeth C. Reed,Kilian E. Salerno,Lee S. Schwartzberg,Amy Sitapati,Karen L. Smith,Mary Lou Smith,Hatem Soliman,George Somlo,Melinda L. Telli,John H. Ward,Rashmi Kumar,Dorothy A. Shead +32 more
TL;DR: This manuscript focuses on the NCCN Guidelines Panel recommendations for the workup, primary treatment, risk reduction strategies, and surveillance specific to DCIS.
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Mitomycin or cisplatin chemoradiation with or without maintenance chemotherapy for treatment of squamous-cell carcinoma of the anus (ACT II): a randomised, phase 3, open-label, 2×2 factorial trial
Roger D James,Rob Glynne-Jones,Helen Meadows,David Cunningham,Arthur Sun Myint,Mark P Saunders,Tim Maughan,Alec McDonald,Sharadah Essapen,Martin Leslie,Stephen Falk,Charles Wilson,Simon Gollins,Rubina Begum,Jonathan A. Ledermann,Latha Kadalayil,David Sebag-Montefiore +16 more
TL;DR: The results of this trial--the largest in anal cancer to date--show that fluorouracil and mitomycin with 50.4 Gy radiotherapy in 28 daily fractions should remain standard practice in the UK.
Journal ArticleDOI
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TL;DR: In this article, the authors provide guidelines which can assist medical, radiation and surgical oncologists in the practical management of this unusual cancer, which is strongly associated with human papilloma virus (HPV, types 16-18) infection.
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Long-Term Update of US GI Intergroup RTOG 98-11 Phase III Trial for Anal Carcinoma: Survival, Relapse, and Colostomy Failure With Concurrent Chemoradiation Involving Fluorouracil/Mitomycin Versus Fluorouracil/Cisplatin
Leonard L. Gunderson,Kathryn Winter,Jaffer A. Ajani,John E. Pedersen,Jennifer Moughan,Al B. Benson,Charles R. Thomas,Robert J. Mayer,Michael G. Haddock,Tyvin A. Rich,Christopher G. Willett +10 more
TL;DR: CCR with FU/MMC has a statistically significant, clinically meaningful impact on DFS and OS versus induction plus concurrent FU /CDDP, and it has borderline significance for CFS, CF, and LRF.
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Anal cancer: ESMO-ESSO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up
Rob Glynne-Jones,Per Nilsson,Carlo Aschele,Vicky Goh,Didier Peiffert,Andrés Cervantes,Dirk Arnold +6 more
TL;DR: In this paper, the authors provide guidelines which can assist medical, radiation, and surgical oncologists in the practical management of this unusual cancer, which is strongly associated with human papilloma virus (HPV) infection.
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TL;DR: Two-stage designs that are optimal in the sense that the expected sample size is minimized if the regimen has low activity subject to constraints upon the size of the type 1 and type 2 errors are presented.
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Marshall S. Flam,Madhu John,Thomas F. Pajak,N. Petrelli,Robert J. Myerson,S Doggett,J Quivey,Marvin Rotman,H Kerman,Lawrence R. Coia,Kevin Murray +10 more
TL;DR: Despite greater toxicity, the use of MMC in a definitive CR regimen for anal cancer is justified, particularly in patients with large primary tumors.
Journal Article
Epidermoid anal cancer: Results from the UKCCCR randomised trial of radiotherapy alone versus radiotherapy, 5-fluorouracil, and mitomycin
S J Arnott,David Cunningham,J Gallagher,Richard Gray,J Hardcastle,J Houghton,Roger D James,T A Lennon,Helen Meadows,J Mossman,Northover Jma.,Morgan Dal.,Piers N. Plowman,M. L. Slevin +13 more
TL;DR: The trial shows that the standard treatment for most patients with epidermoid anal cancer should be a combination of radiotherapy and infused 5-fluorouracil and mitomycin, with surgery reserved for those who fall on this regimen.
Journal ArticleDOI
Combined therapy for cancer of the anal canal : a preliminary report
TL;DR: Surgery has largely supplanted radiation therapy as the primary treatment modality for anal cancer, especially when there is a chance for cure, and these lesions, which lie in close relationship to the dentate line, are neoplasms with rapid growth characteristics.