Clinical trial NCT05142202: High Five (HiFi) Accelerated Partial Breast Irradiation Study
Official title: Doubly Accelerated Partial Breast Irradiation After Breast-Conserving Surgery for Early Breast Cancer - High Five (HiFi) APBI Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
breast-conserving surgery
brachytherapy
High Five
APBI
Lead sponsor: The Greater Poland Cancer Centre
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 147
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To establish the role of adjuvant multicatheter interstitial high-dose-rate brachytherapy in doubly accelerated and radiobiologically equivalent irradiation scheme of 5 x 5,4 Gy in 3 days of treatment (High Five, HiFi-APBI) compared to the adopted long-term standard of APBI realized in 4-5 days (7-8 x 4-4,3 Gy) in selected women with breast low-risk invasive cancer or carcinoma in-situ, in terms of 3-month early and 2-year late toxicity.

Detailed description: Early low-risk breast cancer treatment with high-dose-rate brachytherapy (HDR-BT) (according to GEC-ESTRO, ASTRO, ABS recommendations) as a sole adjuvant treatment to the tumor bed after breast-conserving surgery (BCS) is acknowledged by prominent oncological societies in Poland and the world (PTB - Polish Brachytherapy Society, PTRO - Polish Society for Radiation Oncology, PTO - Polish Society of Oncology, ESTRO, ABS, ASTRO, ASCO). Treatment with multicatheter interstitial HDR-BT in the form of accelerated partial breast irradiation (APBI) was successfully verified in multi-institutional randomized clinical trials (Hungarian trial, GEC-ESTRO trial). It defined the currently widely used oncologically effective and clinically safe irradiation scheme of 8 x Gy in 5 days or 7 x 4,3 Gy in 4 days. In the USA, the irradiation scheme of 10 x 3,4 Gy is widely used in 5-10 days (e.g., NSABP-B39). Some European and American centers are investigating and publishing preliminary results of extremely shortened irradiation schemes of 4 x 6,25 Gy or 3 x 7,5 Gy in 2-3 treatment days, perioperatively (vAPBI trial - Valencia, TRIUMPH-T trial - Phoenix). In the Brachytherapy Department at Greater Poland Cancer Center (GPCC), the listed regimen of 7-8 x 4-4,3 Gy in 4-5 days has been used successfully since 2008. It results in very high local control rates and very low radiation-induced toxicity. APBI after BSC ensures, in properly selected low-risk patients, an equivalent local control rate and lower toxicity compared to whole breast irradiation with external beam radiation therapy (EBRT) The study hypothesis is that an additional moderately shortened irradiation scheme of 5 x 5,4 Gy in 3 consecutive days (two fractions daily with minimal 6 hours gap between fractions) does not increase early toxicity and 2-years late toxicity (primary endpoint). Also, it ensures the same or potentially higher 2-years local control probability compared to the standard regimen (control group).

What is essential, all the above-listed regimens are equivalent in terms of EQD2 calculations. The advantage of higher fraction doses that enable scheme shortening is relatively low radiobiological α/β ratio, estimated for breast cancer at around 4.

The study's primary goal is to prove the possibility of further gradual shortening of the total time of postoperative adjuvant treatment, thus, in the face of increasing breast cancer morbidity, increasing its accessibility. Indirectly, the shortened regimen may decrease the financial burden of the patient and the health system, reduce the patient's oncological treatment-related stress, absence from work, and separation from family. The project feasibility is likely since the only difference between standard and experimental procedures is in the dose and its number.

It's a prospective mono-institutional non-randomized open-label pilot study which results would be a base for further research on larger patients' groups in an anticipated multi-institutional randomized study.

The primary endpoint is to establish the role of adjuvant HDR brachytherapy in the allowable doubly accelerated and radiobiologically equivalent irradiation scheme of 5 x 5,4 Gy in 3 days of treatment (High Five, HiFi-APBI) compared to the adopted long-term standard of APBI realized in 4-5 days (7-8 x 4-4,3 Gy) in patients with breast low-risk invasive cancer or carcinoma in-situ, in terms of 3-month early and 2-year late toxicity.

Secondary endpoints: 1. Assessment of 2-years local control rate; 2. Review of 2-years cosmetic result; 3. Evaluation of the quality of life (QOL); 4. Evaluation of the overall survival (OS), disease-free survival (DFS), and distant metastases free survival (DFMS); 5. Analysis of the performed surgical approaches (tumorectomy, quadrantectomy, oncoplasty) preceding HDR-BT and their influence on the cosmetic results.

It is assumed to recruit a minimum of 60 participants in 2-3 years. The historical control group from the last three years counts over a hundred patients. The study is planned to be continued for up to 5 years to reach a substantially extended follow-up of 2 years.

Assumed causes of study termination: the occurrence of two or more cases of the treated area fat necrosis in which surgical intervention would be necessary (conservative treatment ineffective); too low recruitment (less than one-third of planned); occurrence of two or more similar and earlier not observed cases.

Eligibility criteria: Inclusion Criteria:

* stage 0-II breast cancer
* Invasive ductal carcinoma (NOS, NST, other subtypes), invasive lobular carcinoma, ductal carcinoma in situ (DCIS)
* Invasive carcinoma/DCIS, which is unifocal and unicentric
* pT1-2, maximal tumor size \< 3 cm
* pN0 (no metastases to the nodes)
* LVI(-) - no lymphovascular invasion
* M0 (no distant metastases)
* Surgical margins free of cancer (no tumor on ink) in each direction; in the case of DCIS, the minimum margin of 2 mm in each direction
* Lack of indications to chemotherapy/immunotherapy pre- or postsurgically (e.g., triple-negative, HER2-positive breast cancer)
* Treatment start not later than 12 weeks after surgery (optimally 4-8 weeks, after wound healing)
* Informed handwritten signed patient's consent

Exclusion Criteria:

* stage III-IV breast cancer
* pT2-4, maximal tumor size ≥ 3 cm
* surgical margins cannot be properly microscopically assessed
* EIC(+) - presence of extensive intraductal component
* Paget's disease or microscopically assessed skin involvement
* pN1-3M1 (presence of nodal or distant metastases)
* pre- or postsurgical indications for chemotherapy/immunotherapy
* other cancer (less than five years at time of recruitment) except skin cancer or cured FIGO 0-I cervical cancer
* time of pregnancy or lactation
* collagen disorders (congenital or acquired)
* psychiatric disorder disabling patient's compliance
* breast appearance or postsurgical status disabling safe interstitial multicatheter implantation
* lack of informed handwritten signed patient's consent

Primary outcomes:
measure: Adjuvant treatment - the early toxicity incidence
timeFrame: Up to 48 months
measure: Adjuvant treatment - the late toxicity incidence
timeFrame: up to 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Greater Poland Cancer Centre
state: Greater Poland
Study officials:
affiliation: Greater Poland Cancer Centre
name: Adam Chicheł, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guinot JL, Gonzalez-Perez V, Meszaros N, Major T, Najjari-Jamal D, Gutierrez-Miguelez C, Santos MA, Smanyko V, Laplana M, Polgar C; GEC-ESTRO Breast Working Group2. Very accelerated partial breast irradiation Phase I-II multicenter trial (VAPBI): Feasibility and early results. Brachytherapy. 2021 Mar-Apr;20(2):332-338. doi: 10.1016/j.brachy.2020.10.010. Epub 2020 Nov 19.
citation: Hannoun-Levi JM, Lam Cham Kee D, Gal J, Schiappa R, Hannoun A, Fouche Y, Gautier M, Boulahssass R, Chand ME. Accelerated partial breast irradiation in the elderly: 5-Year results of the single fraction elderly breast irradiation (SiFEBI) phase I/II trial. Brachytherapy. 2020 Jan-Feb;19(1):90-96. doi: 10.1016/j.brachy.2019.10.007. Epub 2019 Nov 23.
citation: Khan AJ, Chen PY, Yashar C, Poppe MM, Li L, Abou Yehia Z, Vicini FA, Moore D, Dale R, Arthur D, Shah C, Haffty BG, Kuske R. Three-Fraction Accelerated Partial Breast Irradiation (APBI) Delivered With Brachytherapy Applicators Is Feasible and Safe: First Results From the TRIUMPH-T Trial. Int J Radiat Oncol Biol Phys. 2019 May 1;104(1):67-74. doi: 10.1016/j.ijrobp.2018.12.050. Epub 2019 Jan 4.
citation: Rivera S, Hannoun-Levi JM. Hypofractionated radiation therapy for invasive breast cancer: From moderate to extreme protocols. Cancer Radiother. 2019 Dec;23(8):874-882. doi: 10.1016/j.canrad.2019.09.002. Epub 2019 Oct 11.
citation: Strnad V, Major T, Polgar C, Lotter M, Guinot JL, Gutierrez-Miguelez C, Galalae R, Van Limbergen E, Guix B, Niehoff P, Lossl K, Hannoun-Levi JM. ESTRO-ACROP guideline: Interstitial multi-catheter breast brachytherapy as Accelerated Partial Breast Irradiation alone or as boost - GEC-ESTRO Breast Cancer Working Group practical recommendations. Radiother Oncol. 2018 Sep;128(3):411-420. doi: 10.1016/j.radonc.2018.04.009. Epub 2018 Apr 21.
citation: Shah C, Vicini F, Shaitelman SF, Hepel J, Keisch M, Arthur D, Khan AJ, Kuske R, Patel R, Wazer DE. The American Brachytherapy Society consensus statement for accelerated partial-breast irradiation. Brachytherapy. 2018 Jan-Feb;17(1):154-170. doi: 10.1016/j.brachy.2017.09.004. Epub 2017 Oct 23.
citation: Lancellotta V, Seipelt L, Hannoun-Levi JM, Tagliaferri L, Chand ME, Perrucci E, Valentini V, Aristei C, Kovacs G, Soror T. Multi-institutional evaluation of the reproducibility and the accuracy of the objective breast cosmesis scale. Brachytherapy. 2018 Nov-Dec;17(6):944-948. doi: 10.1016/j.brachy.2018.07.016. Epub 2018 Aug 24.
citation: Correa C, Harris EE, Leonardi MC, Smith BD, Taghian AG, Thompson AM, White J, Harris JR. Accelerated Partial Breast Irradiation: Executive summary for the update of an ASTRO Evidence-Based Consensus Statement. Pract Radiat Oncol. 2017 Mar-Apr;7(2):73-79. doi: 10.1016/j.prro.2016.09.007. Epub 2016 Sep 17.
citation: Polgar C, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Miguelez CG, Slampa P, Allgauer M, Lossl K, Polat B, Kovacs G, Fischedick AR, Fietkau R, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Potter R, Gall C, Uter W, Strnad V; Groupe Europeen de Curietherapie of European Society for Radiotherapy and Oncology (GEC-ESTRO). Late side-effects and cosmetic results of accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: 5-year results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2017 Feb;18(2):259-268. doi: 10.1016/S1470-2045(17)30011-6. Epub 2017 Jan 14.
citation: Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. November 27, 2017. Access: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm#ctc_50
citation: Vicini F, Shah C, Tendulkar R, Wobb J, Arthur D, Khan A, Wazer D, Keisch M. Accelerated partial breast irradiation: An update on published Level I evidence. Brachytherapy. 2016 Sep-Oct;15(5):607-15. doi: 10.1016/j.brachy.2016.06.007. Epub 2016 Jul 27.
citation: Strnad V, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Gutierrez Miguelez C, Slampa P, Allgauer M, Lossl K, Polat B, Kovacs G, Fischedick AR, Wendt TG, Fietkau R, Hindemith M, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Potter R, Gall C, Malzer M, Uter W, Polgar C; Groupe Europeen de Curietherapie of European Society for Radiotherapy and Oncology (GEC-ESTRO). 5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial. Lancet. 2016 Jan 16;387(10015):229-38. doi: 10.1016/S0140-6736(15)00471-7. Epub 2015 Oct 19.
citation: Brierley JD, Gospodarowicz MK, Wittekind C (Editors). (AJCC) TNM Classification of Malignant Tumours, 8th Edition. 2016, Wiley-Blackwell, www.wiley.com
citation: Strnad V, Hannoun-Levi JM, Guinot JL, Lossl K, Kauer-Dorner D, Resch A, Kovacs G, Major T, Van Limbergen E; Working Group Breast Cancer of GEC-ESTRO. Recommendations from GEC ESTRO Breast Cancer Working Group (I): Target definition and target delineation for accelerated or boost Partial Breast Irradiation using multicatheter interstitial brachytherapy after breast conserving closed cavity surgery. Radiother Oncol. 2015 Jun;115(3):342-8. doi: 10.1016/j.radonc.2015.06.010. Epub 2015 Jun 20.
citation: Perrucci E, Lancellotta V, Bini V, Falcinelli L, Farneti A, Margaritelli M, Capezzali G, Palumbo I, Aristei C. Quality of life and cosmesis after breast cancer: whole breast radiotherapy vs partial breast high-dose-rate brachytherapy. Tumori. 2015 Mar-Apr;101(2):161-7. doi: 10.5301/tj.5000233. Epub 2015 Mar 11.
citation: Cardoso MJ, Oliveira H, Cardoso J. Assessing cosmetic results after breast conserving surgery. J Surg Oncol. 2014 Jul;110(1):37-44. doi: 10.1002/jso.23596. Epub 2014 Mar 13.
citation: Polgar C, Fodor J, Major T, Sulyok Z, Kasler M. Breast-conserving therapy with partial or whole breast irradiation: ten-year results of the Budapest randomized trial. Radiother Oncol. 2013 Aug;108(2):197-202. doi: 10.1016/j.radonc.2013.05.008. Epub 2013 Jun 3.
citation: Cardoso MJ, Cardoso JS, Vrieling C, Macmillan D, Rainsbury D, Heil J, Hau E, Keshtgar M. Recommendations for the aesthetic evaluation of breast cancer conservative treatment. Breast Cancer Res Treat. 2012 Oct;135(3):629-37. doi: 10.1007/s10549-012-1978-8. Epub 2012 Feb 4.
citation: Polgar C, Van Limbergen E, Potter R, Kovacs G, Polo A, Lyczek J, Hildebrandt G, Niehoff P, Guinot JL, Guedea F, Johansson B, Ott OJ, Major T, Strnad V; GEC-ESTRO breast cancer working group. Patient selection for accelerated partial-breast irradiation (APBI) after breast-conserving surgery: recommendations of the Groupe Europeen de Curietherapie-European Society for Therapeutic Radiology and Oncology (GEC-ESTRO) breast cancer working group based on clinical evidence (2009). Radiother Oncol. 2010 Mar;94(3):264-73. doi: 10.1016/j.radonc.2010.01.014. Epub 2010 Feb 22.
citation: Stevens MJ, Cooper SG, Cross P, Wang Y. Accelerated partial breast irradiation using interstitial high dose rate iridium brachytherapy: Early Australian experience and review of the literature. Australas Radiol. 2006 Apr;50(2):143-51. doi: 10.1111/j.1440-1673.2006.01558.x.
citation: Kuske RR, Winter K, Arthur DW, Bolton J, Rabinovitch R, White J, Hanson W, Wilenzick RM. Phase II trial of brachytherapy alone after lumpectomy for select breast cancer: toxicity analysis of RTOG 95-17. Int J Radiat Oncol Biol Phys. 2006 May 1;65(1):45-51. doi: 10.1016/j.ijrobp.2005.11.027. Epub 2006 Feb 28.
citation: Wazer DE, Kaufman S, Cuttino L, DiPetrillo T, Arthur DW. Accelerated partial breast irradiation: an analysis of variables associated with late toxicity and long-term cosmetic outcome after high-dose-rate interstitial brachytherapy. Int J Radiat Oncol Biol Phys. 2006 Feb 1;64(2):489-95. doi: 10.1016/j.ijrobp.2005.06.028. Epub 2005 Oct 24.
citation: Taghian AG, Recht A. Update on accelerated partial-breast irradiation. Curr Oncol Rep. 2006 Jan;8(1):35-41. doi: 10.1007/s11912-006-0007-7.
citation: Chen PY, Vicini FA, Benitez P, Kestin LL, Wallace M, Mitchell C, Pettinga J, Martinez AA. Long-term cosmetic results and toxicity after accelerated partial-breast irradiation: a method of radiation delivery by interstitial brachytherapy for the treatment of early-stage breast carcinoma. Cancer. 2006 Mar 1;106(5):991-9. doi: 10.1002/cncr.21681.
citation: Vicini FA, Arthur DW. Breast brachytherapy: North American experience. Semin Radiat Oncol. 2005 Apr;15(2):108-15. doi: 10.1016/j.semradonc.2004.10.005.
citation: Arthur DW, Vicini FA. Accelerated partial breast irradiation as a part of breast conservation therapy. J Clin Oncol. 2005 Mar 10;23(8):1726-35. doi: 10.1200/JCO.2005.09.045. No abstract available.
citation: Cuttino LW, Todor D, Arthur DW. CT-guided multi-catheter insertion technique for partial breast brachytherapy: reliable target coverage and dose homogeneity. Brachytherapy. 2005;4(1):10-7. doi: 10.1016/j.brachy.2004.11.002.
citation: Ott OJ, Schulz-Wendtland R, Uter W, Pfahlberg A, Beckmann MW, Sauer R, Strnad V. Fat necrosis after conserving surgery and interstitial brachytherapy and/or external-beam irradiation in women with breast cancer. Strahlenther Onkol. 2005 Oct;181(10):638-44. doi: 10.1007/s00066-005-1439-y.
citation: Major T, Fodor J, Takacsi-Nagy Z, Agoston P, Polgar C. Evaluation of HDR interstitial breast implants planned by conventional and optimized CT-based dosimetry systems with respect to dose homogeneity and conformality. Strahlenther Onkol. 2005 Feb;181(2):89-96. doi: 10.1007/s00066-005-1350-6.
citation: Sarin R. Partial-breast treatment for early breast cancer: emergence of a new paradigm. Nat Clin Pract Oncol. 2005 Jan;2(1):40-7. doi: 10.1038/ncponc0071.
citation: Vicini FA, Beitsch PD, Quiet CA, Keleher A, Garcia D, Snider HC, Gittleman MA, Zannis VJ, Kuerer H, Whitacre EB, Whitworth PW, Fine RE, Haffty BG, Arrambide LS. First analysis of patient demographics, technical reproducibility, cosmesis, and early toxicity: results of the American Society of Breast Surgeons MammoSite breast brachytherapy trial. Cancer. 2005 Sep 15;104(6):1138-48. doi: 10.1002/cncr.21289.
citation: Weed DW, Edmundson GK, Vicini FA, Chen PY, Martinez AA. Accelerated partial breast irradiation: a dosimetric comparison of three different techniques. Brachytherapy. 2005;4(2):121-9. doi: 10.1016/j.brachy.2004.12.005.
citation: Reitsamer R, Peintinger F, Sedlmayer F, Kopp M, Cimpoca W, Menzel C. Accelerated partial breast irradiation after conservative surgery for breast cancer. Ann Surg. 2005 Jul;242(1):147-8; author reply 148-9. doi: 10.1097/01.sla.0000169569.09715.c0. No abstract available.
citation: Rivard MJ, Coursey BM, DeWerd LA, Hanson WF, Huq MS, Ibbott GS, Mitch MG, Nath R, Williamson JF. Update of AAPM Task Group No. 43 Report: A revised AAPM protocol for brachytherapy dose calculations. Med Phys. 2004 Mar;31(3):633-74. doi: 10.1118/1.1646040.
citation: Strnad V, Ott O, Potter R, Hildebrandt G, Hammer J, Resch A, Lotter M, Ackermann S, Beckmann MW, Sauer R. Interstitial brachytherapy alone after breast conserving surgery: interim results of a German-Austrian multicenter phase II trial. Brachytherapy. 2004;3(3):115-9. doi: 10.1016/j.brachy.2004.08.003.
citation: Rosenstein BS, Lymberis SC, Formenti SC. Biologic comparison of partial breast irradiation protocols. Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1393-404. doi: 10.1016/j.ijrobp.2004.05.072.
citation: Makarewicz R (red.). Brachyterapia HDR. Via Medica. Gdańsk 2004.
citation: Das RK, Patel R, Shah H, Odau H, Kuske RR. 3D CT-based high-dose-rate breast brachytherapy implants: treatment planning and quality assurance. Int J Radiat Oncol Biol Phys. 2004 Jul 15;59(4):1224-8. doi: 10.1016/j.ijrobp.2004.03.030.
citation: Kuerer HM, Julian TB, Strom EA, Lyerly HK, Giuliano AE, Mamounas EP, Vicini FA. Accelerated partial breast irradiation after conservative surgery for breast cancer. Ann Surg. 2004 Mar;239(3):338-51. doi: 10.1097/01.sla.0000114219.71899.13.
citation: Van Limbergen E. Indications and technical aspects of brachytherapy in breast conserving treatment of breast cancer. Cancer Radiother. 2003 Apr;7(2):107-20. doi: 10.1016/s1278-3218(03)00015-5.
citation: Arthur D. Accelerated partial breast irradiation: a change in treatment paradigm for early stage breast cancer. J Surg Oncol. 2003 Dec;84(4):185-91. doi: 10.1002/jso.10318. No abstract available.
citation: Vicini FA et al. Limited-field radiation therapy in the management of early-stage breast cancer. J Natl Cancer Inst, 2003. 95(16): p. 1205-1210. Arthur DW, Koo D, Zwicker RD, et al. Partial Breast Brachytherapy Following Lumpectomy: a Low Dose Rate and High Dose Rate Experience. Int J Radiat Oncol Biol Phys 2003; 56:681-689.
citation: Arthur DW, Vicini FA, Kuske RR, Wazer DE, Nag S; American Brachytherapy Society. Accelerated partial breast irradiation: an updated report from the American Brachytherapy Society. Brachytherapy. 2003;2(2):124-30. doi: 10.1016/S1538-4721(03)00107-7.
citation: Lawenda BD, Taghian AG, Kachnic LA, Hamdi H, Smith BL, Gadd MA, Mauceri T, Powell SN. Dose-volume analysis of radiotherapy for T1N0 invasive breast cancer treated by local excision and partial breast irradiation by low-dose-rate interstitial implant. Int J Radiat Oncol Biol Phys. 2003 Jul 1;56(3):671-80. doi: 10.1016/s0360-3016(03)00071-3.
citation: Polgar C, Sulyok Z, Fodor J, Orosz Z, Major T, Takacsi-Nagy Z, Mangel LC, Somogyi A, Kasler M, Nemeth G. Sole brachytherapy of the tumor bed after conservative surgery for T1 breast cancer: five-year results of a phase I-II study and initial findings of a randomized phase III trial. J Surg Oncol. 2002 Jul;80(3):121-8; discussion 129. doi: 10.1002/jso.10110.
citation: Wazer DE, Berle L, Graham R, Chung M, Rothschild J, Graves T, Cady B, Ulin K, Ruthazer R, DiPetrillo TA. Preliminary results of a phase I/II study of HDR brachytherapy alone for T1/T2 breast cancer. Int J Radiat Oncol Biol Phys. 2002 Jul 15;53(4):889-97. doi: 10.1016/s0360-3016(02)02824-9.
citation: Vicini FA, Baglan KL, Kestin LL, Mitchell C, Chen PY, Frazier RC, Edmundson G, Goldstein NS, Benitez P, Huang RR, Martinez A. Accelerated treatment of breast cancer. J Clin Oncol. 2001 Apr 1;19(7):1993-2001. doi: 10.1200/JCO.2001.19.7.1993.
citation: Wazer DE, Lowther D, Boyle T, Ulin K, Neuschatz A, Ruthazer R, DiPetrillo TA. Clinically evident fat necrosis in women treated with high-dose-rate brachytherapy alone for early-stage breast cancer. Int J Radiat Oncol Biol Phys. 2001 May 1;50(1):107-11. doi: 10.1016/s0360-3016(00)01541-8.
citation: King TA, Bolton JS, Kuske RR, Fuhrman GM, Scroggins TG, Jiang XZ. Long-term results of wide-field brachytherapy as the sole method of radiation therapy after segmental mastectomy for T(is,1,2) breast cancer. Am J Surg. 2000 Oct;180(4):299-304. doi: 10.1016/s0002-9610(00)00454-2.
citation: Nag S, Kuske RR, Vicini FA, Arthur DW, Zwicker RD. Brachytherapy in the treatment of breast cancer. Oncology (Williston Park). 2001 Feb;15(2):195-202, 205; discussion 205-7. doi: 10.1016/s0167-8140(01)80063-3.
citation: Polgar C, Major T, Somogyi A, Fodor J, Toth J, Sulyok Z, Forrai G, Takacsi-Nagy Z, Mangel LC, Nemeth G. Sole brachytherapy of the tumor bed after breast conserving surgery: a new radiotherapeutic strategy for patients at low risk of local relapse. Neoplasma. 1999;46(3):182-9.
citation: Vicini F, Kini VR, Chen P, Horwitz E, Gustafson G, Benitez P, Edmundson G, Goldstein N, McCarthy K, Martinez A. Irradiation of the tumor bed alone after lumpectomy in selected patients with early-stage breast cancer treated with breast conserving therapy. J Surg Oncol. 1999 Jan;70(1):33-40. doi: 10.1002/(sici)1096-9098(199901)70:13.0.co;2-o.
citation: Kuske RR Jr. Breast brachytherapy. Hematol Oncol Clin North Am. 1999 Jun;13(3):543-58, vi-vii. doi: 10.1016/s0889-8588(05)70074-5.
citation: Nath R, Anderson LL, Luxton G, Weaver KA, Williamson JF, Meigooni AS. Dosimetry of interstitial brachytherapy sources: recommendations of the AAPM Radiation Therapy Committee Task Group No. 43. American Association of Physicists in Medicine. Med Phys. 1995 Feb;22(2):209-34. doi: 10.1118/1.597458. No abstract available.
citation: Cox JD, Stetz J, Pajak TF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6. doi: 10.1016/0360-3016(95)00060-C. No abstract available.
citation: Harris JR, Levene MB, Svensson G, Hellman S. Analysis of cosmetic results following primary radiation therapy for stages I and II carcinoma of the breast. Int J Radiat Oncol Biol Phys. 1979 Feb;5(2):257-61. doi: 10.1016/0360-3016(79)90729-6. No abstract available.