Optimizing multimodality treatment for head and neck cancer in rural India

Symposium: Head and Neck Optimizing multimodality treatment for head and neck cancer in rural India Trivedi NP 1,2, Trivedi P 1, Trivedi H 1, Trivedi S 1, Trivedi N 1,2 1 Trivedi Polyclinic and Nursing Home, Mehsana, Gujarat, 2 Mazumdar Shaw Cancer Center and NH, Bangalore, India Correspondence to: Dr. Nirav P Trivedi, E-mail: dr_niravtrivedi@yahoo.com Abstract BACKGROUND: Multimodality treatment of head and neck cancer in rural India is not always feasible due to lack of infrastructure and logistics. AIM: To demonstrate the feasibility of multimodality treatment for head and neck cancer in a community setting in rural India. SETTING AND DESIGN: Community cancer center, retrospective review. MATERIALS AND METHODS: This article focuses on practice environment in a cancer clinic in rural India. We evaluated patient profile, treatment protocols, infrastructure availability, factors impacting treatment decisions, cost estimations, completion of treatment, and major treatment-related complications for the patient population treated in our clinic for a 2-year period. RESULTS: A total of 230 head and neck cancer patients were treated with curative intent. Infrastructure support included basic operating room facility (cautery machine, suction, drill system, microscope, and anesthesia machine without ventilator support), blood bank, histopathology laboratory, and computerized tomography machine. Radiation therapy (RT) facility was available in a nearby city, about 75 km away. One hundred and fifty-four (67%) patients presented at an advanced stage, with 138 (60%) receiving multimodality treatment. One hundred and eighty-four (80%) patients underwent primary surgery and 167 (73%) received radiotherapy. Two hundred and twelve (92%) patients completed the treatment, 60 (26%) were lost to follow-up at 18-month median follow-up (range 12 26 months), with 112 patients (66%) being alive, disease free. Totally 142 were major head neck surgeries with 25 free flap reconstructions and 41 regional flaps. There were 15 (6%) major post-op complications and two perioperative mortalities. Average cost of treatment for single modality treatment was approximately 40,000 INR and for multimodality treatment was 80,000 INR. CONCLUSIONS: This study demonstrates that it is feasible to provide basic multimodality treatment to head and neck cancer patients in the community. Key words: Community, head and neck cancer, multimodality treatment, rural India Introduction Delivering health care in resource-constrained community is a major challenge. A number of factors apart from disease have an impact on treatment feasibility. Actual outcome in a community setting may be different from that in trial settings. [1-3] Head and neck cancer is more prevalent in developing countries and accounts for about one-third of all cancer cases. [4,5] It is more prevalent in communities in rural part of India due to use of Quick Response Code: Access this article online Website: www.indianjcancer.com DOI: 10.4103/0019-509X.102917 PMID: ******* known etiological factors like tobacco and alcohol. [6-11] Patients largely present at an advanced stage and need multimodality care. [5] In a large developing country like India, it may not be feasible to centralize treatment of cancer due to large volume, logistics, and associated cost. [1] Providing optimal cancer care is difficult in a rural setting with limited resources, and hence many patients either may not receive treatment or may receive suboptimal treatment compromising outcome. [12,13] This article focuses on key issues in delivering multimodality cancer care in rural India and shares our experience in delivering protocol-based treatment for this population. Materials and Methods This article focuses on the practice environment in a cancer clinic in rural India. The authors have Indian Journal of Cancer April-June 2012 Volume 49 Issue 2 225

experience in treating head and neck cancer patients in the rural clinic since 1981. All patients treated in Trivedi polyclinic and cancer center from January 2007 to December 2008 were included in this study and a retrospective chart review was done. Surgical oncology and medical oncology treatment were delivered in our center situated in a small town. Radiotherapy (RT) treatment was delivered in a regional cancer center about 75 km away. We followed a pre-decided treatment protocol for every patient and close co-ordination was carried out between both centers to ensure appropriate treatment. All relevant aspects of treatment delivery are discussed subsequently. This article mainly focuses on issues on delivering multimodality treatment to rural population, as follows: Infrastructure availability Establishing multidisciplinary tumor board (MDT) Adhering treatment protocol Finance and logistics Our outcome in terms of patient profile, efficacy in treatment delivery, treatment-related complications, and finances are discussed in the Results section. Outcome with limited follow-up (median follow-up 18 months; range 12 26 months) is also discussed to have an idea about efficacy of treating patients in such a setup. Aim of this article is to focus on feasibility of effective treatment delivery and means to improve it. All relevant points are discussed accordingly. Results We attended around 290 new head and neck cancer cases during the 2-year (2007 2008) period and ultimately treated 250 patients. Two hundred and thirty patients underwent curative intent treatment and we have focused on this group for outcome evaluation. Patient profile is listed in Table 1. One hundred and twenty patients had oral cancer, 50 had laryngeal cancer, 30 had pharyngeal cancer, 10 had paranasal sinus cancer, 10 had salivary gland cancer, and 10 had thyroid cancer. One hundred and fifty-four (67%) patients presented with advanced disease. Table 2 shows the treatment offered to various head and neck cancers. A total of 138 (60%) patients received multimodality treatment, while 92 (40%) patients received single modality treatment. Of 120 oral cavity patients, 26 had oral tongue floor of mouth cancers, 70 gingivobuccal (GB) sulcus cancers, 4 lip cancers, 14 alveolus cancers, and 6 had hard palate cancers. Thirty patients underwent wide local excision (WLE) without involving mandible (mainly tongue and palate), 30 had marginal mandibulectomy done (GB sulcus), and 60 had segmental mandibulectomy done (mainly GB sulcus 226 and alveolus). Reconstruction was obtained by primary closure in 32 cases, local flaps in 22 cases, regional flap in 41 cases, and free flap in 25 cases. Margins were positive in seven cases and re-resected in four cases. As a policy, we did neck dissection clearing level I V in all patients. Majority of patients with advanced larynx and hypopharynx cancers underwent total laryngectomy and partial pharyngectomy. Four patients underwent total laryngopharyngectomy and reconstruction with free jejunum (1), free anterolateral flap (1), and tube pectoralis major (PMMC) flap (2). Primary tracheoesophageal puncture (TEP) with valve was done in 20 cases and 13 patients were speaking well at 2-year follow-up. Paranasal sinus cancers were treated by total maxillectomy in eight cases, with free rectus flap reconstruction in four cases. Two anterior craniofacial resections were performed by subcranial approach with the help of a neurosurgeon for dural closure. A total of 184 (80%) patients underwent primary surgery in our series. There were two perioperative deaths due to pulmonary embolism. Fifteen patients (6%) had major complications in the perioperative period. Ten patients had surgery-related complications, while five patients had anesthesia-related complications. Two patients with free flap needed re-exploration due to hematoma compressing the veins and both the flaps were salvaged. Two patients had massive postoperative bleeding secondary to infection, but both were salvaged by ligating carotid arteries without any neurological consequences. Six patients had partial necrosis of flap and wound infections, but were managed conservatively. Two patients needed reintubation and elective ventilation for further 3 4 h, but recovered well afterward. Three patients developed Table 1: Patient profile Patient population Number Oral cavity 120 Early stage * 30 Advanced stage + 90 Larynx 50 Early stage * 20 Advanced stage + 30 Pharynx 30 Early stage * 6 Advanced stage + 24 Paranasal sinus 10 Thyroid 10 Salivary gland 6 Other 4 *Early stage Stage I, II (T1, T2 N0 M0) +Advanced stage Stage III, IV non-metastatic (T3, T4 N+, M0) Indian Journal of Cancer April-June 2012 Volume 49 Issue 2

Table 2: Treatment for various head and neck cancers Cancer/treatment Surgery (patients) Surgery + radiation/ CTRT (patients) Radiation (patients) Chemoradiation (CTRT) (patients) Early oral 30 0 0 0 Advanced oral 15 75 0 0 Early larynx 0 0 20 0 Advanced larynx 2 18 2 8 Early pharynx 1 0 5 0 Advanced pharynx 0 14 2 8 Paranasal sinus 2 8 0 0 Thyroid 10 0 0 0 Salivary gland 3 3 0 0 Other 0 3 1 Total 63 121 29 17 chest infection and one patient was eventually shifted to another center with intensive care unit (ICU) for ventilator support. Patient compliance was good in majority of the cases. Totally 212 (92%) patients completed the whole treatment. Eight patients refused to take adjuvant RT due to financial (4), logistical (2), and cultural (2) reasons. Four patients did not take adjuvant radio-iodine treatment due to non-availability. Six patients stopped the prescribed RT / CTRT treatment midway due to various reasons. Patients were encouraged for regular follow-up at least once in 6 months for 2 years duration. Table 3 shows the outcome at a median follow-up of 18 months (range 12 26 months). Sixty patients (26%) were lost to follow-up and the outcome of remaining 170 patients was evaluated. Totally 41 patients (24%) died, of whom 23 (14%) died of unrelated causes. A total of 12 (7%) patients died of distant metastasis, while 5 (3%) died of recurrent local disease. Totally 23 (14%) developed loco-regional recurrence. About 112 (66%) patients were alive and disease free at the time of last follow-up. Only limited results in terms of oncological outcome are discussed here as the focus of this study is to address the issues in delivering multimodality treatment. Average cost for ablative cancer resection and reconstruction with loco-regional flaps came to approximately 40,000 45,000 INR. This included all the investigations, all hospital and doctors charges, and the medicine cost (calculated based on final bill). Average hospital stay was for 8 days. This cost increased to about 60,000 70,000 INR for complex surgeries with free flap reconstructions. Approximate cost for RT in regional cancer center was 10,000 INR for threedimensional conventional RT, while it was about 25,000 INR for intensity-modulated RT (IMRT). Total cost for Table 3: Follow-up results at median 18 months (range 12 26 months) multimodality in majority of cases ranged from 60,000 to 100,000 INR. Discussion No. (%) Total patients 230 (100) Lost to follow-up 60 (26) Alive disease free 112 (66) Died 41 (24) Died due to unrelated cause 23 (13) Died due to distant metastasis 12 (7) Loco-regional recurrence 23 (14) Died due to loco-regional recurrence 5 (3) Head and neck cancer treatment has made significant progress in the past few decades. Improved results are mainly due to implementation of multimodality treatment, better imaging techniques, and efficient treatment delivery. It is important to focus on delivering multimodality treatment to everyone in the community, which can have significant impact on the overall outcome. This aspect of cancer care is largely neglected in the literature. Treating a patient with head and neck cancer in rural area is a daunting task. A number of factors play as an important role as disease stage itself. Our center has experience in treating head neck cancer patients since 1981. Treatment methodology and protocols have evolved with time and our focus has shifted from single modality to multimodality treatment. In this article, we share our experience in establishing protocol-based treatment and multimodality care in our center. The key issues such as the following are discussed in length: Infrastructure availability Indian Journal of Cancer April-June 2012 Volume 49 Issue 2 227

Establishing MDT Adhering treatment protocol Finance and logistics Infrastructure availability Treatment for head and neck cancer is complex and needs appropriate infrastructure and support services. This may not be available in smaller towns in India and can be one of the major limiting factors in treating these patients. Surgical treatment requires operating room with few specialized instruments, facility for imaging and histopathology, blood bank, and facility for ICU. It may be difficult to have all the facilities in one institute in a small town, but different hospitals and laboratories in the town can co-ordinate to provide such services. Our center is located in the small town of Mehsana which has a population of approximately 1 lakh, but drains significantly larger patient population from the surrounding villages. The setup of our hospital is similar to that of a general surgical or ENT (ear-nose-throat) clinic. There are two surgeons trained for head and neck surgery, one otolaryngologist, one anesthetist, and one medical oncologist providing cancer care. It has two operating theaters with basic infrastructure like cautery machine, anesthesia trolley with no automatic ventilator facility (manual positive pressure ventilation), basic cardiac monitor, and one operating ENT-microscope. Facility for ICU is not available in the hospital, but another hospital in town provides support if needed. Medical oncologist and anesthetist team up as critical care physicians and pain palliation clinicians. We have totally seven persons as paramedics, including two operation theater assistants, two nurses, and three other staff members. The clinic has a separate out-patient department equipped with facility for basic ENT examination. The town has two imaging centers with computed tomography (CT) scanning facility, three pathology laboratories with facility for blood investigations and histopathology reporting, and one blood bank. Results of our series demonstrate if it is feasible to perform majority of head and neck surgical procedures with optimal infrastructure (major complications 6%). It is necessary to arrange adequate units of blood and check the availability of anesthetist and staff for re-exploration while planning a major surgery or free flap reconstruction. Co-ordination with ICU doctor is also necessary in case the patient requires postoperative ventilation. Our policy has been to perform elective tracheostomy in all major procedures. With appropriate planning and necessary caution, majority of the head and neck surgical procedures can be performed with limited infrastructure. The setup described above is 228 available in majority of towns in India and it is more of motivation and co-ordination that is required to achieve a satisfactory outcome. Availability of RT in smaller towns is a major limiting factor in delivering multimodality treatment. We do not have facility for RT in the town, and the nearest facility is in a city about 70 75 km away. All the patients needing RT were referred to this regional cancer center with prior appointment. Patients were appropriately explained about the need for adjuvant treatment and were aggressively followed up to ensure completeness of treatment. Arranging for logistics to complete 6 7 weeks of RT is difficult for some patients. Our patients have a strong family and community support and relatives have a major say in selecting the treatment options and in arranging finances and logistics. Patients and relatives can be convinced to receive appropriate treatment in majority of cases with proper counseling (92% completed treatment). Multidisciplinary tumor and treatment protocols Implementation of protocol-based treatment is essential in achieving consistency in outcome in our country. Establishing multidisciplinary tumor board and adhering pre-decided treatment guidelines is the first step in achieving this. It is not possible to strictly follow guidelines prepared in developed nations in our country due to resource constraints. We modified National Comprehensive Cancer Network (NCCN) and Tata hospital guidelines to formulate a guideline feasible in our setup. [14,15] In our experience, patient compliance is significantly more if the treatment duration is short. Patients also prefer treatment that requires minimal subsequent intervention which reduces cost and time of follow-up. Organ preservation treatment with chemoradiotherapy in quite intense and requires support services and strict follow-up schedule. They may need subsequent salvage if primary treatment fails. Entire treatment is of long duration and may need significant finances and logistics. We preferred conventional approach of surgery with adjuvant RT for patients with advanced cancers. This is one of the limitations of practicing in a rural area, but gives more chance of completing multimodality treatment. Organ preservation treatment may be feasible in a rural setting, but we have limited experience with it and a separate study is needed to evaluate it. Multidisciplinary tumor board was established by the surgical and medical oncologists working in the same institute. We strictly adhered to the treatment guidelines developed at out center and patients were referred for RT (adjuvant or primary) accordingly. All patients were followed up aggressively till the completion of Indian Journal of Cancer April-June 2012 Volume 49 Issue 2

treatment. All patients were encouraged to follow-up once in 3 months for the first year and then at every 6 months. Extent of resection and choice of reconstruction also plays an important part in minimizing perioperative complications. We err on the side of resecting more to obtain negative margins and using reconstruction options which are simple and reliable. (Free fibula bone reconstruction is reserved for anterior mandibular defects while soft tissue flaps are preferred for distal segmental resections.) We perform tracheostomy in majority of cases to avoid respiratory complications in the postoperative period. Nutrition support and rehabilitation services are of extreme importance and a diet chart consisting of local preparation and elective feeding jejunostomy at the time of primary surgery have helped. Most of the patients are physically fit due to village lifestyle, and this may be one of the reasons for lesser morbidity in our series. Finance and logistics Patient resources also pay a major role in selecting the treatment options in our country. Many patients in rural areas earn their living on a daily basis, and shorter treatment duration with ability to join work early takes priority over other issues. Conventional treatment options of radical surgery and adjuvant RT are more feasible in terms of finances and logistics. Average cost for single and multiple modality treatment in our series was acceptable for majority of the patients. We did not offer organ preservation treatment or treatment with targeted molecules to many patients and cannot make any comments on the viability of these treatment options. This study has many limitations if considered as an oncological outcome-based study. Disease stage, type and extent of treatment, and outcome in terms of survival are not discussed in detail. However, outcome of our study with limited follow-up (median 18 months) is comparable to that reported in other studies from our country. [16] This article mainly focuses on the feasibility of delivering multimodality, protocolbased treatment in a resource-constrained setup, and the outcome is given just to have an idea about the feasibility of such an approach. Important issues contributing to its feasibility (appropriate treatment selection, co-ordination between centers, and motivation of clinicians) are discussed in depth along with appropriate results. This article may not add anything new to literature in terms of improvement in survival, but aims to add a new dimension in improving head and neck cancer care in rural India. We hope that our experience may motivate and help other clinicians in optimizing treatment protocols in their setup. Conclusions This study demonstrates the feasibility of multimodality treatment for head neck cancer in communities in rural areas. 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Hillner BE, Smith TJ, Desch CE. Hospital and physician volume or specialization and outcomes in cancer treatment: Importance in quality of cancer care. J Clin Oncol 2000;18:2327-40. 14. National Comprehensive Cancer Network (NCCN) Guidelines, version 1. 2008. 15. TMH Handbook: Evidence Based Medicine, Head and Neck Cancers, 2005. 16. Yeole BB, Sankaranarayanan R, Sunny MScL, Swaminathan R, Parkin DM. Survival from head and neck cancer in Mumbai (Bombay), India. Cancer 2000;89:437-44. How to cite this article: Trivedi NP, Trivedi P, Trivedi H, Trivedi S, Trivedi N. Optimizing multimodality treatment for head and neck cancer in rural India. Indian J Cancer 2012;49:225-9. Source of Support: Nil, Conflict of Interest: Nil. Indian Journal of Cancer April-June 2012 Volume 49 Issue 2 229