|MINI SYMPOSIUM: HEAD AND NECK
|Year : 2012 | Volume
| Issue : 1 | Page : 6-10
Head and neck cancer in India: Need to formulate uniform national treatment guideline?
NP Trivedi, VD Kekatpure, NN Trivedi, MA Kuriakose
Department of Head and Neck Oncology, Mazumdar-Shaw Cancer Center, Narayana Hrudayalaya, Bangalore, India
|Date of Web Publication||25-Jul-2012|
N P Trivedi
Department of Head and Neck Oncology, Mazumdar-Shaw Cancer Center, Narayana Hrudayalaya, Bangalore
Background: In a large and diverse country like India, there is a wide variation in the availability of infrastructure and expertise to treat head-neck cancer patients. Lack of consistent adherence to evidence-based management is the biggest problem. Aims: There is an unmet need to evaluate the existing treatment practices to form the basis for development of effective and uniform treatment policies. Settings and Designs: Prospective case series. Materials and Methods: A group of previously treated, potentially curable patients presenting to our institution (from April 2009 to March 2011) were evaluated for appropriateness of initial treatment based on National Comprehensive Cancer Network or Tata Memorial Hospital guidelines. Data regarding treatment center, protocol and accuracy of delivered treatment and their eventual outcome were analyzed. Statistical Analysis: Descriptive. Results: Amongst 450 newly registered patients, 77(17%) were previously treated with curative intent and 69(89%) of them were inappropriately treated. Seventeen (25%) patients were treated in clinics while 12(17%) in cancer centers and 34(50%) in corporate hospitals. Fourteen (20%) patients received chemotherapy, 22(32%) received radiotherapy and 14(20%) underwent surgery while 19(28%) patients received multimodality treatment. Disease stage changed to more advanced stage in 40(58%) patients and curative intent treatment could be offered only to 33(48%) patients. Amongst 56 patients available for outcome review, 18(32%) patients were alive disease-free, 20(36%) had died and 18(32%) were alive with disease. Conclusion: Large numbers of potentially curable patients are inappropriately treated and their outcome is significantly affected. Many initiatives have been taken in the existing National Cancer Control Program but formulation of a uniform national treatment guideline should be prioritized.
Keywords: Evidence-based medicine, head and neck cancer, India, National Cancer Control Program, treatment guideline
|How to cite this article:|
Trivedi N P, Kekatpure V D, Trivedi N N, Kuriakose M A. Head and neck cancer in India: Need to formulate uniform national treatment guideline?. Indian J Cancer 2012;49:6-10
|How to cite this URL:|
Trivedi N P, Kekatpure V D, Trivedi N N, Kuriakose M A. Head and neck cancer in India: Need to formulate uniform national treatment guideline?. Indian J Cancer [serial online] 2012 [cited 2013 May 21];49:6-10. Available from: http://www.indianjcancer.com/text.asp?2012/49/1/6/98907
| » Introduction|| |
Head and neck cancer is the most common cancer in India. ,, Treatment of head and neck cancer has changed significantly with the advent of multimodality treatment. Improved outcomes with multimodality treatment are linked to availability of appropriate infrastructure, expertise and strict adherence to treatment protocols. In a large and diverse country like India where treatment environment varies significantly between different centers, lack of consistency in delivering treatment is the biggest drawback. Large numbers of head and neck cancer patients receive inappropriate or inadequate treatment adversely affecting the outcome. Therefore, there is an urgent need to develop uniform national guidelines for effective treatment delivery. The Indian Council of Medical Research (ICMR) formulated the National Cancer Control Program (NCCP) in 1975-76 which forms the backbone for cancer control in India.  Various initiatives have been taken to improve cancer care in our country but sustained efforts are needed towards development and implementation of proper treatment guidelines. ICMR has developed guidelines for buccal cancer but they are not uniformly followed.  There is paucity of data regarding treatment protocols, treatment delivery and actual outcome of head and neck cancer treatment in our country in diverse settings. In this study, we highlight the fact that many patients are inappropriately treated with significant impact on their outcome and propose changes for developing uniform treatment guidelines.
| » Materials and Methods|| |
After approval from the institutional review board, we retrospectively reviewed charts of all new patients enrolled in the head and neck tumor board at our center from April 2009 to March 2011. Patients with history of previous treatment were classified into a separate category from the ones newly diagnosed. In the previously treated group, patients amenable and treated with curative intent (based on AJCC (American Joint Committee on Cancer) staging system) were selected and further sub-classified into properly and inappropriately treated patients. For this study, patients treated according to either NCCN (National Comprehensive Cancer Network) or Tata Hospital (Mumbai, India) guidelines were deemed appropriately treated, whereas patients treated with any deviation were considered inappropriately treated. , Amongst the inappropriately treated group of patients, data regarding demography, treatment centers and their facilities, disease stage before treatment and at present, intent of previous treatment, and protocol and accuracy of delivered treatment were noted. We also recorded our treatment decision in terms of intent and type of treatment offered. Treating centers were divided into three categories depending upon their infrastructure, treating clinicians and practice trends. Centers with the facility to treat patients with only single modality (surgery/chemotherapy/radiotherapy) or where treating clinicians lacked proper training were classified as clinics. Patients in clinics were treated without the help of a multidisciplinary tumor board, mainly by clinicians who did not have adequate experience or infrastructure to manage cancer patients (otolaryngologists or general surgeons or physicians). Centers with the facility to treat patients with multi-modalities but not having proper tumor board facility were classified as hospitals (mainly corporate hospitals). In these corporate hospitals, though the majority of facilities were available for cancer treatment, treatment decisions were based on the discretion of individual clinicians and lacked uniform policies or a multidisciplinary tumor board. Centers with all facilities available and a registered tumor board (where treatment decisions were made by a multidisciplinary team) were classified as cancer centers. These contained government-run cancer centers as well as private institute with facilities and tumor board registries.
These patients were regularly followed up and their outcome at the time of review was analyzed.
| » Results|| |
A total of four hundred and fifty new patients with head and neck cancer were registered in our tumor board during the two-year period from March 2009 to April 2011. Eighty-eight patients (20%) presented with history of previous treatment received at other centers. Eleven (12.5%) of those patients were treated with palliative intent due to their advanced stage. Seven of these patients had advanced local disease (T4, N3) and four had metastatic disease in lung. These patients were excluded from the final analysis. Amongst the remaining 77 (17% of all new cases) patients, eight (11%) received appropriate treatment while 69 (89%) patients did not receive proper treatment according to either NCCN or Tata Hospital guidelines. Of these eight patients appropriately treated, three had early-stage disease (Stage I, II) and five had advanced-stage (Stage III, IV) loco-regional disease. All other 69 patients with inappropriate treatment were included in the final analysis. Fifteen (22%) of 69 patients with inappropriate treatment had early-stage (I, II) disease.
Mean age of patients in the selected group was 48 years (range 12 to 77 years). There were 24 female patients and 45 male patients. Oral cancer was the most common site (46) at presentation [Table 1]. Buccal mucosa was the most common subsite (26) followed by tongue (10) cancer. Seventeen (25%) patients were treated in clinics while 12 (17%) patients were treated in cancer centers. The largest number of patients (34-50%) was treated in corporate hospitals. Six (9%) patients received treatment in more than one center. Fourteen (20%) patients received chemotherapy (CT) alone, 22 (32%) received radiotherapy (RT) alone and 14 (20%) underwent surgery alone. Nineteen (28%) patients received multimodality treatment but treatment protocol was different from the standard of care for that particular stage of disease. Of the patients who received only chemotherapy (14), five had early-stage (I, II) disease and nine had advanced-stage disease. While four patients were treated in clinics by physicians, others were treated by medical oncologist in institutes. Amongst 26 patients who received chemotherapy, 20 had inappropriate regime and 21 had inadequate dose and schedule. All 30 patients who received RT either had inappropriate dose, inappropriate protocol or improper fractionation schedule. Out of 22 patients receiving only RT, 16 had advanced-stage disease. About 14 patients received surgery alone and 10 of them had advanced-stage disease and four of them were treated in clinics. Of 18 patients who underwent surgery, neck was not addressed appropriately in 10 cases and the choice and extent of primary resection (based on imaging studies) was improper in 11 cases.
Seventy-eight percent patients had advanced-stage disease and 72% patients were treated by single-modality treatment. Treating patients with advanced-stage disease using single-modality treatment appears to be the main pattern for improper treatment. And in a few cases where patients received multimodality care, protocol selection and treatment delivery was faulty. It is also evident, based on the findings listed above that patients received improper treatment for all stages of the disease (more for advanced stages), in different types of practice settings, and by various clinicians. This is a heterogeneous group of patients, practice settings and type of treatment. It would have been ideal to find out the exact reasons which compelled clinicians to opt for these treatment options in each case. This is a retrospective study and limited with data available from recorded sheets.
In 40 (58%) patients, the disease stage changed (to more advanced stage) from the first presentation to the time they registered with our tumor board. Curative intent treatment could be offered only to 33 (48%) of the 69 patients at our center at their current disease status. The remaining 36 patients were treated with palliative intent therapy. Amongst these 33 patients who underwent curative intent treatment, 20 were from the group of 29 who did not progress and 13 from the group of 40 who had progressive disease. All the decisions were made by tumor board in multidisciplinary panel and it is not possible to list the reasons for the selection of treatment in each case as it includes a variety of issues beyond disease status. Thirteen patients were lost to follow-up and the remaining 56 patients' outcome was evaluated at review. For eight months' median follow-up (range 4 to 24 months), 18 (32%) patients were alive and disease-free, 20 (36%) patients had died, and 18 (32%) patients were alive with disease. Out of 33 patients with curative intent treatment, 31 were available for review and 17 (55%) of them were alive without disease. Mean disease-free survival for the rest of the 14 patients was nine months after curative intent treatment.
| » Discussion|| |
The current Indian population is approximately 1.2 billion. Head and neck cancer is the commonest cancer in India and consists of about one-third of all cancers. ,, According to the Indian Council of Medical Research (ICMR) Atlas More Details, approximately 0.2 to 0.25 million new head and neck cancer patients are diagnosed each year. , There are 19 regional cancer centers (RCCs) all across India.  These are government-supported comprehensive cancer centers and they form the backbone of cancer care in India. The existing infrastructure is clearly not enough for optimal cancer care for the entire population. In the absence of a centralized system to deal with the head and neck cancer load in our country, patients are treated in various treatment environments with different treatment modalities. Meticulous adherence to treatment guidelines across the community that is essential for optimal cancer care and which forms the basis for future advancement is lacking in our country.
The results of our study further substantiate these facts. Eighty-nine percent (69) of all previously treated patients presented with improper treatment to our center which is located in an urban setting. The majority of patients had advanced-stage disease and yet received single-modality treatment. In 58% (40) cases the disease progressed and curative intent treatment could be offered only in 33 (48%) cases. Amongst 56 patients for outcome evaluation, only 32% (18) patients were alive and disease-free at the time of review. This outcome is unacceptable compared to the standard outcome in an otherwise potentially curable group of patients in our country.  Though these are small numbers to draw major conclusions, this does reflect the common feeling amongst practicing clinicians. Moreover, most of these patients were treated in urban areas where treatment facilities are good and treating professionals are well-trained. The actual incidence in rural and other underdeveloped areas can be even higher and further studies are needed to evaluate this. Reasons for inappropriate treatment can vary from unavailability of infrastructure, finance, lack of proper training, lack of a treatment guideline to suit their environment and other social and religious factors. It would have been ideal to evaluate reasons for inadequate treatment in each case but it was not feasible from the available data source. A further prospective study focusing on issues related to inappropriate treatment could throw more light on this subject.
This problem is multifaceted and we need to formulate a strong system to overcome it. In order to provide optimal head and neck cancer treatment to every patient, one needs a large number of properly equipped cancer centers, trained professionals to run these centers and a uniform treatment guideline that can be followed across the community. The NCCP was launched in 1975-76 with the objectives of primary prevention, early detection, treatment and rehabilitation.  In order to cater to the changing needs of the disease the program has undergone three revisions, with the third revision in December 2004. Under the revised program, the primary focus is on correcting the geographic imbalance in the availability of cancer care facilities across the country. The scope of the program and the quantum of assistance under the various schemes have been increased. 
Currently there are 19 RCCs which is far too less for our country. Though the number of private cancer centers is increasing, the majority of our population still faces financial constraints and can afford complete cancer treatment only at government-supported centers. Based on existing cancer registries and the capacity of cancer centers to treat patients, the government needs to significantly increase the number of RCCs. This has been proposed in the last revision of the NCCP. There are well-formed guidelines for establishing a new RCC and providing continuous support to existing RCCs. An initiative had been taken to develop an oncology wing in existing medical colleges and to provide financial assistance to manage it. The scope of this has been extended to government hospitals not affiliated with medical colleges and clear guidelines are laid down. In addition, a minimum requirement guideline can be established for any other private center to be able to treat head and neck cancer patients. This will ensure minimum infrastructure availability in every center, potentially avoiding inappropriate treatment through lack of equipments.
Training enough professionals to treat such a large number of patients is another major challenge. We have multiple training programs which vary significantly in the quality of training. There is no central curriculum or no central evaluation system to accredit them. Regional centers have a training program but the number is far too less. There are no centralized guidelines for centers in terms of infrastructure, teaching faculty and curriculum to run a teaching program. With very few properly trained professionals being unable to manage large volumes, a significant proportion of the patient population is being treated by inadequately trained professionals. Though there are initiatives taken to train various health professionals in managing cancer under NCCP, these focus more on the awareness aspect and core training of clinicians treating patients is largely ignored. There is an urgent need to establish a central education committee to address these issues.
Providing adequate infrastructure and trained professionals can be a daunting task and may take a long time. This study also demonstrates that patients are treated out of standard protocol even in properly equipped and appropriately staffed cancer centers (17%). Formulating uniform national guidelines and making clinicians accountable to follow it can be the first step in restructuring the system. This will instill consistency and accountability amongst treating clinicians and also provide them a basis for sound clinical practice. ICMR has developed guidelines for the treatment of buccal cancer but they are not uniformly followed and this aspect is largely ignored for other sub-sites in the current strategy of NCCP.  The feasibility of various treatment protocols should be evaluated in our practice environment and uniform guidelines can be formed accordingly. These guidelines should also consider financial, logistical and social factors prevailing in the community. A clear outline to deliver each major treatment modality should be documented. Any newer modality shou be included in this guideline only with its feasibility requirements. The feasibility of running an open tumor board by RCCs should also be evaluated. Any clinician across the country should have online access to this tumor board and should be able to register any case for guidance and a group of experts can be given the responsibility to coordinate. This strategy can help clinicians avail valuable guidance and would help us achieve consistency. Forming guidelines would not only streamline patient management but would also help generate clinical data which could be used for further studies and to formulate future policies.
There has been paucity of data regarding the actual impact of the NCCP on the treatment of head and neck cancer in India and this limited study has provided an opportunity to evaluate the existing scenario. A National Task Force for developing a "Strategy for Cancer Control in India during the 11 th Five-Year Plan" had been constituted, focusing on number of issues discussed in this article.  Based on the results of this study, formulating uniform treatment guidelines for management of head and neck cancer in India should be given due importance in future policies.
| » Conclusion|| |
Large numbers of potentially curable patients are inappropriately treated and their outcome is significantly affected. Formulation of uniform treatment guidelines across the country should be prioritized in future policies.
| » References|| |
|1.||Sankaranarayanan R, Masuyer E, Swaminathan R, Ferlay J, Whelan S. Head and neck cancer: A global perspective on epidemiology and prognosis. Anticancer Res 1998;18:4779-86. |
|2.||Sanghvi LD, Rao DN, Joshi S. Epidemiology of head and neck cancer. Semin Surg Oncol 1989;5:305-9. |
|3.||Takiar R, Nadayil D, Nandakumar A. Projections of number of cancer cases in India (2010-2020) by cancer groups. Asian Pac J Cancer Prev 2010;11:1045-9. |
|4.||National Cancer Control Programme (1975-76), India. |
|5.||Indian council of medical research (ICMR): Guidelines for Management of Buccal Mucosa Cancer, 2010. |
|6.||National Comprehensive Cancer Network (NCCN) Guidelines, version 1.2008. |
|7.||TMH Handbook: Evidence Based Medicine, Head and Neck Cancers, 2005. |
|8.||Indian council of medical research (ICMR): An Atlas for Cancer in India (2002). |
|9.||Yeole BB, Sankaranarayanan R, Sunny M Sc L, Swaminathan R, Parkin DM. Survival from head and neck cancer in Mumbai (Bombay), India. Cancer 2000;89:437-44. |