INTRAOPERATIVE RADIATION THERAPY

Transcription

1 INTRAOPERATIVE RADIATION THERAPY Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Medical Coverage Guidelines are subject to change as new information becomes available. For purposes of this Medical Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS, BLUE SHIELD and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. Description: Intraoperative radiation therapy (IORT) is a technique to increase the intensity of radiation delivered directly to tumors. The tumor and associated tissues at risk for metastatic spread are directly visualized during surgery and IORT is delivered directly to the tumor. Normal or uninvolved tissues are not exposed to radiation because they are removed or shielded from the treatment field. O453.9.docx Page 1 of 7

2 Criteria: For intraoperative accelerated partial breast irradiation for treatment of breast cancer, see BCBSAZ Medical Coverage Guideline, Brachytherapy for Treatment of Breast Cancer. Intraoperative radiation therapy for the treatment of rectal cancer is considered medically necessary with documentation of ANY of the following: 1. T4 lesions with positive or close margins 2. Recurrent disease Intraoperative radiation therapy for all other indications not previously listed or if above criteria not met is considered experimental or investigational based upon: 1. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 2. Insufficient evidence to support improvement of the net health outcome, and 3. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives. Resources: BCBS Association Medical Policy Reference Manual. Intraoperative Radiation Therapy. Re-issue date 08/14/2014, issue date 10/08/ Ballo MT, Zagars GK, Pollock RE, et al. Retroperitoneal soft tissue sarcoma: an analysis of radiation and surgical treatment. Int J Radiat Oncol Biol Phys Jan ;67(1): Barsukov IuA, Vlasov OA, Tkachev SI, et al. [Use of combined treatment of rectal cancer involving metastases to regional lymph nodes]. Vopr Onkol ;52(5): Bergenfeldt M, Albertsson M. Current state of adjuvant therapy in resected pancreatic adenocarcinoma. Acta Oncol ;45(2): Beroukas E, Peponi E, Soulimioti G, et al. Intraoperative electron beam radiotherapy followed by moderate doses of external beam radiotherapy in the treatment of resected soft tissue sarcomas of the extremities. J BUON Oct-Dec 2004;9(4): O453.9.docx Page 2 of 7

3 6. Caudle AS, Tepper JE, Calvo BF, et al. Complications associated with neoadjuvant radiotherapy in the multidisciplinary treatment of retroperitoneal sarcomas. Ann Surg Oncol Feb 2007;14(2): Chen AM, Bucci MK, Singer MI, et al. Intraoperative radiation therapy for recurrent head-andneck cancer: the UCSF experience. Int J Radiat Oncol Biol Phys Jan ;67(1): Chen AM, Garcia J, Bucci MK, et al. Recurrent salivary gland carcinomas treated by surgery with or without intraoperative radiation therapy. Head Neck Jan 2008;30(1): Crane CH, Beddar AS, Evans DB. The role of intraoperative radiotherapy in pancreatic cancer. Surg Oncol Clin N Am Oct 2003;12(4): Drognitz O, Henne K, Weissenberger C, et al. Long-term results after intraoperative radiation therapy for gastric cancer. Int J Radiat Oncol Biol Phys Mar ;70(3): Dziewirski W, Rutkowski P, Nowecki ZI, et al. Surgery combined with intraoperative brachytherapy in the treatment of retroperitoneal sarcomas. Ann Surg Oncol Feb 2006;13(2): Fu S, Lu JJ, Zhang Q, Yang Z, Peng L, Xiong F. Intraoperative radiotherapy combined with adjuvant chemoradiotherapy for locally advanced gastric adenocarcinoma. Int J Radiat Oncol Biol Phys Dec ;72(5): Garcia Sabrido JL, Velasco Sanchez E, Calvo F, et al. [Intraoperative therapeutic intensification techniques in locally advanced abdominal sarcomas]. Cir Esp Oct 2006;80(4): Gillis AM, Sutton E, Dewitt KD, et al. Long-term outcome and toxicities of intraoperative radiotherapy for high-risk neuroblastoma. Int J Radiat Oncol Biol Phys Nov ;69(3): Gunderson LL, Haddock MG, Kapp DS, Miller RC, Callister MG, Gottschalk A. Intraoperative Radiation Therapy. Textbook of Radiation Oncology, 3rd Edition. 12/01/ Holmes DR, Baum M, Joseph D. The TARGIT trial: targeted intraoperative radiation therapy versus conventional postoperative whole-breast radiotherapy after breast-conserving surgery for the management of early-stage invasive breast cancer (a trial update). Am J Surg Oct 2007;194(4): O453.9.docx Page 3 of 7

4 17. Houtmeyers P, Breusegem C, Ceelen W, et al. Intraoperative high-dose-rate brachytherapy (IBT) for locally unresectable intraabdominal malignancy. Acta Chir Belg Sep-Oct 2007;107(5): Ihse I, Andersson R, Ask A, Ewers SB, Lindell G, Tranberg KG. Intraoperative radiotherapy for patients with carcinoma of the pancreas. Pancreatology ;5(4-5): Intra M, Leonardi C, Luini A, et al. Full-dose intraoperative radiotherapy with electrons in breast surgery: broadening the indications. Arch Surg Oct 2005;140(10): Kaiser GM, Fruhauf NR, Lang H, et al. Impact of intraoperative radiotherapy (IORT) on survival of patients with unresectable hilar cholangiocarcinoma. Hepatogastroenterology Nov-Dec 2008;55(88): Kienle P, Abend F, Dueck M, Abel U, Treiber M, Riedl S. Influence of intraoperative and postoperative radiotherapy on functional outcome in patients undergoing standard and deep anterior resection for rectal cancer. Dis Colon Rectum May 2006;49(5): Kraus-Tiefenbacher U, Bauer L, Kehrer T, Hermann B, Melchert F, Wenz F. Intraoperative radiotherapy (IORT) as a boost in patients with early-stage breast cancer -- acute toxicity. Onkologie Mar 2006;29(3): Kraus-Tiefenbacher U, Bauer L, Scheda A, et al. Intraoperative radiotherapy (IORT) is an option for patients with localized breast recurrences after previous external-beam radiotherapy. BMC Cancer ;7: Kraus-Tiefenbacher U, Scheda A, Steil V, et al. Intraoperative radiotherapy (IORT) for breast cancer using the Intrabeam system. Tumori Jul-Aug 2005;91(4): Kunieda E, Hirobe S, Kaneko T, Nagaoka T, Kamagata S, Nishimura G. Patterns of local recurrence after intraoperative radiotherapy for advanced neuroblastoma. Jpn J Clin Oncol Aug 2008;38(8): Kusters M, Holman FA, Martijn H, et al. Patterns of local recurrence in locally advanced rectal cancer after intra-operative radiotherapy containing multimodality treatment. Radiother Oncol Mar Lemanski C, Azria D, Thezenas S, et al. Intraoperative radiotherapy given as a boost for early breast cancer: long-term clinical and cosmetic results. Int J Radiat Oncol Biol Phys Apr ;64(5): O453.9.docx Page 4 of 7

5 28. Ma HB, Di ZL, Wang XJ, Kang HF, Deng HC, Bai MH. Effect of intraoperative radiotherapy combined with external beam radiotherapy following internal drainage for advanced pancreatic carcinoma. World J Gastroenterol Jun ;10(11): Masaki T, Takayama M, Matsuoka H, et al. Intraoperative radiotherapy for oncological and function-preserving surgery in patients with advanced lower rectal cancer. Langenbecks Arch Surg Mar 2008;393(2): Mathis KL, Nelson H, Pemberton JH, Haddock MG, Gunderson LL. Unresectable colorectal cancer can be cured with multimodality therapy. Ann Surg Oct 2008;248(4): Merrick HWr, Gunderson LL, Calvo FA. Future directions in intraoperative radiation therapy. Surg Oncol Clin N Am Oct 2003;12(4): Messick C, Hardacre JM, McGee MF, et al. Early experience with intraoperative radiotherapy in patients with resected pancreatic adenocarcinoma. Am J Surg Mar 2008;195(3): ; discussion Mitsunaga S, Kinoshita T, Kawashima M, et al. Extrahepatic portal vein occlusion without recurrence after pancreaticoduodenectomy and intraoperative radiation therapy. Int J Radiat Oncol Biol Phys Mar ;64(3): Mussari S, Sabino Della Sala W, Busana L, et al. Full-dose intraoperative radiotherapy with electrons in breast cancer. First report on late toxicity and cosmetic results from a singleinstitution experience. Strahlenther Onkol Oct 2006;182(10): Nakagohri T, Kinoshita T, Konishi M, Takahashi S, Tanizawa Y. Clinical results of extended lymphadenectomy and intraoperative radiotherapy for pancreatic adenocarcinoma. Hepatogastroenterology Mar 2007;54(74): O'Connor JK, Sause WT, Hazard LJ, Belnap LP, Noyes RD. Survival after attempted surgical resection and intraoperative radiation therapy for pancreatic and periampullary adenocarcinoma. Int J Radiat Oncol Biol Phys Nov ;63(4): Oertel S, Niethammer AG, Krempien R, et al. Combination of external-beam radiotherapy with intraoperative electron-beam therapy is effective in incompletely resected pediatric malignancies. Int J Radiat Oncol Biol Phys Jan ;64(1): O453.9.docx Page 5 of 7

6 38. Oertel S, Treiber M, Zahlten-Hinguranage A, et al. Intraoperative electron boost radiation followed by moderate doses of external beam radiotherapy in limb-sparing treatment of patients with extremity soft-tissue sarcoma. Int J Radiat Oncol Biol Phys Apr ;64(5): Okamoto A, Matsumoto G, Tsuruta K, et al. Intraoperative radiation therapy for pancreatic adenocarcinoma: the Komagome hospital experience. Pancreas Apr 2004;28(3): Qin HL, Lin CH, Zhang XL. Evaluation of intraoperative radiotherapy for gastric carcinoma with D2 and D3 surgical resection. World J Gastroenterol Nov ;12(43): Reitsamer R, Sedlmayer F, Kopp M, et al. The Salzburg concept of intraoperative radiotherapy for breast cancer: results and considerations. Int J Cancer Jun ;118(11): Rosato FE. The role of intraoperative radiation therapy in the treatment of locally advanced unresectable pancreatic adenocarcinoma. Proc Am Soc Clin Onco, 2003 ASCO Annual Meeting ; Ruano-Ravina A, Almazan Ortega R, Guedea F. Intraoperative radiotherapy in pancreatic cancer: a systematic review. Radiother Oncol Jun 2008;87(3): Schueller P, Micke O, Palkovic S, et al. 12 years' experience with intraoperative radiotherapy (IORT) of malignant gliomas. Strahlenther Onkol Aug 2005;181(8): Shimizu Y, Yasui K, Fuwa N, Arai Y, Yamao K. Late complication in patients undergoing pancreatic resection with intraoperative radiation therapy: gastrointestinal bleeding with occlusion of the portal system. J Gastroenterol Hepatol Aug 2005;20(8): Sunamura M, Karasawa K, Okamoto A, et al. Phase III trial of radiosensitizer PR-350 combined with intraoperative radiotherapy for the treatment of locally advanced pancreatic cancer. Pancreas Apr 2004;28(3): Tran PT, Hara W, Su Z, et al. Intraoperative radiation therapy for locally advanced and recurrent soft-tissue sarcomas in adults. Int J Radiat Oncol Biol Phys Nov ;72(4): Tran PT, Su Z, Hara W, Husain A, Teng N, Kapp DS. Long-term survivors using intraoperative radiotherapy for recurrent gynecologic malignancies. Int J Radiat Oncol Biol Phys Oct ;69(2): Tran QN, Kim AC, Gottschalk AR, et al. Clinical outcomes of intraoperative radiation therapy for extremity sarcomas. Sarcoma ;2006(1): O453.9.docx Page 6 of 7

7 50. Valentini V, Calvo F, Reni M, et al. Intra-operative radiotherapy (IORT) in pancreatic cancer: joint analysis of the ISIORT-Europe experience. Radiother Oncol Apr 2009;91(1): Valentini V, Coco C, Rizzo G, et al. Outcomes of clinical T4M0 extra-peritoneal rectal cancer treated with preoperative radiochemotherapy and surgery: a prospective evaluation of a single institutional experience. Surgery May 2009;145(5): Valentini V, Morganti AG, Macchia G, et al. Intraoperative radiation therapy in resected pancreatic carcinoma: long-term analysis. Int J Radiat Oncol Biol Phys Mar ;70(4): Wada M, Hosotani R, Kajiwara T, Kokubo M. Outcome of Phase II Study of Intraoperative Radiation Therapy and External-Beam Radiation Therapy Plus Gencitabine in Patients with Locally Advanced Pancreatic Cancer. Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings ;23(16S). 54. Willett CG, Del Castillo CF, Shih HA, et al. Long-term results of intraoperative electron beam irradiation (IOERT) for patients with unresectable pancreatic cancer. Ann Surg Feb 2005;241(2): Yamaguchi K, Kobayashi K, Ogura Y, et al. Radiation therapy, bypass operation and celiac plexus block in patients with unresectable locally advanced pancreatic cancer. Hepatogastroenterology Sep-Oct 2005;52(65): Yamaguchi K, Nakamura K, Kobayashi K, et al. ERT following IORT improves survival of patients with resectable pancreatic cancer. Hepatogastroenterology Jul-Aug 2005;52(64): O453.9.docx Page 7 of 7