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Journal of Cancer Research and Therapeutics, Vol. 6, No. 4, October-December, 2010, pp. 530-536 Original Article Patterns of locoregional treatment of breast cancer among radiation oncologists in India: A practice survey Ashwini Budrukkar, Manpreet Tiwana, Rakesh Jalali, Anusheel Munshi, Rajiv Sarin Department of Radiation Oncology, Tata Memorial Hospital, Parel, Mumbai - 400 012, India Correspondence Address: Ashwini Budrukkar, Department of Radiation Oncology, Tata Memorial Hospital, Parel, Mumbai - 400 012, India, ashwininb@yahoo.com Code Number: cr10130 PMID: 21358094 DOI: 10.4103/0973-1482.77065 Abstract Background: The objective of the study was to assess and evaluate the practice patterns of locoregional treatment of early and advanced breast cancer among radiation oncologists (ROs) in India.Materials and Methods: This questionnaire-based survey was served to practicing ROs through electronic mails and personal communication between November 2006 and March 2008. Patterns of practices with respect to locoregional treatment of breast cancer in patients with ductal carcinoma in situ, early breast cancer (EBC), locally advanced and metastatic breast cancer (MBC) were studied. Results: We analyzed sixty completed forms from ROs in India. The median number of breast cancer patients evaluated per year by the treating oncologist was 130, wherein EBC comprised 30%; locally advanced breast cancer (LABC), 50%; and MBC, 20%. A median 46% of the ROs favored breast-conserving therapy (BCT) in EBC and 92% of this subgroup advised adjuvant radiation therapy (RT) in BCT. For LABC, a majority 90% of the respondents advocated a modified radical mastectomy, whereas 42% chose to include the axilla in their RT portals. Conclusions: The survey highlights the prevalent varied treatment policies followed across the country and encourages us to understand and adopt a uniform consensus for the management of breast cancer. Keywords: Breast cancer, practice survey, radiation therapy, surgery Introduction Breast cancer is a heterogeneous disease and requires multidisciplinary management approach. [1],[2] Surgery and radiation therapy (RT) are the important modalities for locoregional control of breast cancer. [3],[4] Numerous guidelines have evolved over the last decade for management of breast cancer but strict implementation and incorporation of their methodology is crucial for the ultimate benefit of patients. Practice surveys and patterns of care studies in countries like U.S.A. and Japan have been conducted at regular intervals to monitor the quality of treatment offered to the patient, and each subsequent survey has demonstrated a significant improvement in management policies in regard to breast cancer at all levels of oncologic care. [5],[6] In countries with limited resources, there is wide variation in the available facilities for the treatment as well as expertise related to surgical skills, RT, and medical oncology. In addition, there is lack of supporting staff that can influence complex treatments and their implementation. These issues can therefore influence the treatment considered by the oncologist for his/her patient population. A regular appraisal is critical for any clinical establishment and we felt the need of quality assurance survey for a large and populous geography like India. The primary aim of the current study was to assess and evaluate the practice patterns of locoregional treatment of breast cancer prevalent among the radiation oncologists (ROs) of India in general and do a comparative analysis in regard to established current practice guidelines or norms set by available evidence. Materials and Methods The analysis was conducted through a questionnaire-based survey on the patterns of locoregional treatment of breast cancer in India through an ROs′ perspective. The questionnaire was a three-page document comprising thirty-one questions formatted in simple scientific language, addressing the management policies on locoregional treatment of early, locally advanced, and metastatic breast cancer (MBC) [Table - 1]. The target cohort of ROs were selected from the national registry of Association of Radiation Oncologists of India, and the said questionnaire was distributed by the authors through electronic mails, and personal communication at various oncology national conferences held in India over a period between November 2006 and March 2008. Though any number of responses per center was acceptable, we did not encourage multiple entries from a single radiation oncology center. The concerning ROs were requested to complete the questionnaire and return the same to one of the authors on their electronic mail, postal addresses, or personally hand over the document, if possible. The data were statistically analyzed on SPSS software (version 15.0; SPSS, Inc, Chicago, IL) and the relevant descriptive analysis, independent samples t-test, and chi-square test to compare proportions were utilized. Two independent groups were created for analysis, one being the affiliate center of the RO whether academic or nonacademic, and the other group being the years of expertise in the field of radiation oncology, cut off being kept at 10 years. Results We received sixty completed forms for assessment of this survey. Of these, 9 (15%) were received through electronic mails, whereas the remaining 51 (85%) were retrieved personally by the authors during oncology meetings. The ROs were subclassified with respect to institutional affiliation and years of expertise. Twenty (33%) ROs had academic affiliation, whereas 40 (67%) had nonacademic affiliation. In regards to years of expertise, 39 (65%) ROs had <10 years and 21 (35%) ROs had >10 years of expertise. The median number of total patients of breast cancer seen per year by each oncologist was 130 (range, 10-1500), wherein early breast cancer (EBC) comprised 30%; locally advanced breast cancer (LABC), 50%; and MBC, 20% of the total number of breast cancer patients seen by the ROs. Preinvasive Cancer Ductal carcinoma in situ (DCIS) The details of the management policies followed by the ROs for patients with DCIS in this survey are shown in [Table - 2]. Forty-one (68%) respondents preferred doing a wide excision (W/E) in DCIS, of which 20 (33%) recommended it with supplementary axillary dissection. For adjuvant RT after breast-conserving surgery (BCS), 32 (53%) ROs suggested giving RT while 22 (37%) considered adjuvant RT only, based on risk stratification. In patients who have undergone mastectomy for DCIS, 28 (47%) ROs felt that there is no need of adjuvant RT, whereas 22 (37%) of them advised adjuvant RT based on risk stratification. Invasive Cancer- Early Breast Cancer (EBC) [Table - 3] summarizes the management policies followed by the ROs for EBC. Surgery ROs preferred BCS in 46% of the patients, whereas mastectomy was favored in 42%. In the remaining 12%, simple mastectomy was considered. Forty-four (74 %) ROs felt that patients with multifocality, lobular histology, and unwillingness did not qualify for a breast conservative surgery. Also, 45 (75%) of the pooled sample did not advise for a sentinel node biopsy (SNLB) in EBC. No statistical difference between the two independent groups was observed. Axillary clearance up to level 2 was favored by 35 (58%) oncologists, whereas the remaining 23 (39%) considered complete axillary clearance in EBC as a standard procedure for the management of axilla. There was a statistically significant difference observed among institution practice, wherein 30 of ROs affiliated to academic institutes offered axillary clearance up to level 2, whereas 14 of the nonacademic ROs preferred a complete axillary clearance (P = 0.001). Radiation Therapy (RT) Fifty-five (92%) of the ROs considered adjuvant RT after BCS, of which 40 of the respondents considered RT only to the breast, 8 considered irradiating supraclavicular fossa in addition to breast, 7 included axilla in addition to breast and supraclavicular region, and 5 considered irradiation of internal mammary chain (IMC). Twenty-six (43%) ROs considered use of telecobalt for the treatment of breast-conserving therapy (BCT), whereas 13 (22%) ROs considered both machines for BCT. Regarding fractionation, 40 (67%) ROs approved of 50Gy/25# schedule for EBC undergoing BCS, whereas 14 (23%) preferred a 45Gy/25# schema for their subset of patients. Surprisingly, none of the participants considered hypofractionated treatment for their patients undergoing BCT. Fifty-one (85%) ROs of the pooled data unequivocally offered tumor bed boost to their patients; however, the choice of modality differed according to the institutions, with ROs at academic institutions preferring brachytherapy (P = 0.07). Concerning boost dose, there were 10 different dose fractionation schedules followed, but the majority 14 ROs (24.1%) among the variance preferred 15Gy/6#, barring any alliance either to institution or years of expertise. Only 12 (20%) ROs advocated for radical brachytherapy in EBC. Locally Advanced Breast Cancer [Table - 4] summarizes the salient management decisions adopted by the ROs in treating LABC. Surgery ROs in this study considered mastectomy as the optimum treatment for 90% of their patients, whereas in 10%, they considered BCT. Radiation therapy The entire respondent ROs (100%) adhered to giving adjuvant RT in LABC irrespective of surgical modality, with no disparity with respect to institution or years of expertise. Five different adjuvant RT dose fractionations were considered by the ROs with most common fractionation being 50Gy/25#/5 weeks given by 47 (82%) oncologists. Twenty-five (42%) ROs chose to include the axilla in their RT portals irrespective of surgical dissection. Whereas 21 (38%)ROs included axilla only in the event of inadequate axillary dissection or gross residual axillary disease. Overall, 33 (55%) consented to giving posterior axillary boost as well. Thirteen (22%) ROs practiced treating the IMC citing medial quadrant tumor with axilla positive or a medial tumor >3 cm as the requisite indications, and a majority of the ROs preferred wide tangential portals for the same. Metastatic Breast Cancer (MBC) Forty-nine (82%) ROs responded in affirmation to giving local treatment to the involved breast in MBC, wherein 27 (45%) ROs cited fungation as their main indication in providing local treatment to this subset of patients. Discussion Healthcare providers have been chiefly implicated in several studies as the key factors in determining the outcome in breast cancer. [7] We explored the various policies and management principles practiced by ROs across India through a questionnaire-based survey on locoregional management of breast cancer. About 70% of patients are seen in advanced stages, with 50% being LABC and 20% MBC. This is in sharp contrast to the western population where majority of the patients present with early-stage breast cancer. This possibly is due to lack of organized screening programs and also awareness among the population regarding breast cancer. Ductal Carcinoma in situ Preinvasive cancer forms a very small percentage of patients in the entire spectrum of breast cancer in India. Therefore, it appears that there is no much consensus regarding the treatment of breast as well as axilla among our oncologists. Supported with results of randomized clinical trials, the use of standard BCT with lumpectomy and adjuvant conventional whole breast irradiation is most commonly recommended treatment in a focal DCIS presentation. [8],[9] However, mastectomy is more appropriate for women with high-risk features of multicentricity or a diffuse DCIS. [8] Though our survey shows that only 53% of the ROs offer adjuvant RT to BCS in DCIS, European Organisation for Research and Treatement of Cancer (EORTC) and National Surgical Adjuvant Breast and Bowel Project (NSABP) trials have clearly demonstrated that the adjuvant RT in the said clinical scenario reduces the local recurrence rate to less than 10% and improves the cure rate to 95%. [8],[9] Optimal approach among the RO is seen lacking through the survey, especially in the management of axilla, as about 33% preferred axillary dissection along with a lumpectomy. Axillary dissection is strongly debated in DCIS, rather no axillary staging procedure is validated for a patients with DCIS. [10],[11],[12] Invasive Cancer- Early Breast Cancer (EBC) Surgery Although BCT in the form of wide excision with axillary clearance is considered as the standard of care for stage I and II breast cancer patients and results in survival equivalent to that observed after mastectomy, it was offered to only 46% patients by our oncologist. [13],[14] However, modified radical mastectomy remains the standard of the care when disease is multicentric, lobular histology, or a doubtful compliance to adjuvant RT, a fact concurrent with 73% of the ROs in the survey. [13],[14] This disparity in the adoption of surgical modality in the Indian scenario could likely be explained due to various treatment- and patient-related factors. Access to optimal surgical expertise, bulky tumors at presentation, limited radiation oncology infrastructure in terms of advanced equipment like linear accelerators, and lack of expertise for the planning and treatment of RT for BCT makes conservation difficult in Indian scenario. SNLB is standard likely option for patients with EBC, further stating avoidance of axillary lymph node dissection (ALND) when SLNs are negative. [15] Recent randomized trials have already proved a less surgical morbidity and better quality of life for SLNB alone compared with ALND. [16],[17],[18] SLNB is best considered based on individual risk factors, treatment responsiveness, and the utility of systemic therapy, though the controversial current standard of care is to do completion ALND in patients with positive SLNB. [15],[18] However, a majority of 75% in our survey did not opt for SLNB. This possibly is due to lack of surgical expertise, especially dedicated breast surgeons in India. In addition, SLNB requires infrastructure in terms of frozen section facility that is not available in many centers. Therefore, axillary clearance is favored method of treatment of axilla by our ROs. Radiation Therapy RT is an integral component of treatment of breast cancer with BCT which has impact not only on the local recurrence rates, but also on the overall survival. [19] Furthermore, an addition of boost dose of 16 Gy to standard 45-50 Gy whole breast irradiation significantly reduces the risk of local recurrence, especially in younger patients less than 50 years of age. [20] In our series, 92% of ROs recommended RT after BCT and 85% of these considered boost to the tumor bed for their patients. The RT recommended dose is equivalent to 45-50 Gy of whole breast along with tumor bed boost with electrons or 192 Iridium implant (Low dose rate or High dose rate) equivalent to 10-15 Gy is recommended in all EBCs undergoing BCS. [20],[21] A majority of ROs (90%) in the survey concurred with this dose/fractionation regime in this group of patients. Surprisingly, none of the ROs opted for hypofractionated regimens. Hypofractionation is being increasingly considered for patients treated with BCT. [22] It has huge and favorable resource implications, especially in country like India where the resources are limited. However, use of hypofractionated regimen requires careful patient selection and appropriate planning and implementation. in situations where it is not done considering all of the above situations, it can have poor outcome in terms of long-term cosmesis. [23] Although linear accelerator is the preferred machine for treatment, especially for patients with EBC, due to its skin sparing affect, 65% of ROs in our study considered treatment with telecobalt. This is in contrast with the data from west where large majority of the patients for EBC are treated with linear accelerators. This shows the resource constraints in our country. We studied the prevalence and choice of modality for tumor bed boost, where academic institutes significantly favored interstitial implant. This difference may be due to personal experience/expertise, patient compliance, and implication of resource and logistics. The EORTC Trial 22881/10882 trial comprising 2661 patients evaluated interstitial implant and electrons as modality for tumor bed boost, but found no differences as far as local control and cosmesis/toxicity is concerned, despite a lower treatment volume and a longer overall treatment time. [24] In our own series of 1022 women treated with BCT for EBC, we have observed no difference in the local control rates with interstitial implant or electrons. However, the late sequelae in terms of breast indurations were significantly higher in women treated with high-dose rate brachytherapy of 10 Gy in single fraction. [25] Radiation to axilla has been a highly debated issue. Combined surgery and irradiation have shown increased toxicity with respect to arm edema without improving the regional control. Therefore, RT is not recommended in patients with completely dissected axilla as the recurrence rates are low. In our study, 20% of the RO still preferred axillary radiation in their RT portals in node negative EBC undergoing BCT. This possibly could be due to lack of surgical expertise and inadequacy of axillary surgery. A small number of ROs (20%) advocated the use of radical brachytherapy in EBC. Accelerated partial breast irradiation (APBI) is a promising approach, especially in small selected subgroup of women with age more than 40 years, tumors <3 cm, with pathologically free margins and negative axillary lymph nodes. A randomized trial by Polgár et al. has shown comparable outcome with APBI when compared with whole breast irradiation or standard BCT. [26] In addition, data from many prospective series have shown promising results. [27],[28] Few more randomized trials are ongoing at present to address this issue and till that time APBI remains to be an investigational modality. Although it can have resource-sparing implications in terms of machine space, its use in developing countries will still be limited due to larger tumors at presentation. Locally Advanced Breast Cancer Surgery and NACT (neoadjuvant chemotherapy) Mastectomy was the most preferred treatment in patients with LABC. BCT was considered only for 10% of the patients with LABC by our ROs. For patients with advanced operable breast cancer, mastectomy upfront followed by adjuvant chemotherapy and RT is an appropriate treatment algorithm, while those with inoperable lesions should be offered NACT as a standard of care. [29],[30],[31] NSABP-18 trial elucidated the fact that there is higher rates of recurrence in patients with advanced lesions that were treated with BCS after NACT (15.7%) than small lesions that were treated with surgery first (7.6%). [32] Radiation Therapy All (100%) of the ROs considered postoperative RT for their patients with LABC, which is consistent with the standard practice all over the world. [33] Although routine postoperative irradiation of axilla is not recommended unless there is known or suspected residual axillary disease, nearly 42% of ROs in the survey always included axilla in their RT portals. This could possibly be due to surgical inadequacy or a doubtful axillary clearance, as discussed earlier. Twenty-two percent of the ROs practiced treating the IMC citing medial quadrant tumor with axilla positive or a median tumor size >3 cm as the requisite indications. However, routine irradiation of internal mammary nodes is still not considered standard of care, pending the results of the large EORTC trial examining the survival benefit of IMC RT due to possible cardiac morbidity / mortality with IMC irradiation. [34] Metastatic Breast Cancer Though locoregional treatment in MBC is a highly controversial issue, it is generally not considered except for palliation of symptoms. In our survey, 82% of the ROs advised local RT to the breast citing fungation as the chief cause of their prescription. This survey was the first attempt to study and recognize the variability of treatment regimens for management of breast cancer across India from an ROs′ perspective. Though the sample number is small with its inherent statistical limitations but it definitely points toward inhomogeneity of the breast cancer management policies that exist among ROs from all over the country vis-a-vis established guidelines. Hence, there is a need for collaborative effort to improve the resources as well as standard of care in the management of breast cancer. Conclusions We observed nonuniformity in the patterns and practices of locoregional treatment among Indian ROs. The resource constraint situations were observed, as large majority of the ROs still considered telecobalt for the treatment of EBC. Only 46% of the patients with EBC were considered for BCT, which could further be improved. Role of RT in LABC is well established now, with all the ROs offering RT for the same. However, there appears to be no consensus regarding irradiation of axilla and IMC chain. References
Copyright 2010 - Journal of Cancer Research and Therapeutics The following images related to this document are available:Photo images[cr10130t4.jpg] [cr10130t2.jpg] [cr10130t1.jpg] [cr10130t3.jpg] |
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