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Evidence Based Management Gingivo-Buccal Cancer

Evidence Based Management Gingivo-Buccal Cancer. Dr. A D’ Cruz Tata Memorial Hospital. Oral Cancer – Global Incidence. 10th most common cancer 389,000 new cases annually (2000) 2/3 rd in developing countries 200,000 deaths annually. Stable or increased in last four decades

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Evidence Based Management Gingivo-Buccal Cancer

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  1. Evidence Based Management Gingivo-Buccal Cancer Dr. A D’ Cruz Tata Memorial Hospital

  2. Oral Cancer – Global Incidence • 10th most common cancer • 389,000 new cases annually (2000) • 2/3rd in developing countries • 200,000 deaths annually • Stable or increased in last four decades • Sharp increase in incidence in Germany, Denmark, Scotland, • Central & Eastern Europe • Same increase in Japan, Australia, New Zealand & USA ( non-whites)

  3. Oral Cancers Oral cancer common cancer in India – Observations reported since late 19th century

  4. Cancer of the oral cavitySite Distribution TONGUE & FOM GINGIVOBUCCAL COMPLEX [BUCCAL MUCOSA + RMT + LOWER GUM]

  5. Biological Distinctions in Oral Cancer

  6. GINGIVOBUCCAL CANCER – THE INDIAN ORAL CANCER 2275 PTS. (1997-99)

  7. Gingivo-Buccal Cancers Areca nut is the fourth most common psychoactive substance in the world (after caffeine, alcohol and nicotine), the use extending to several hundred million people. Tobacco chewers (with cancer) 105 AGE AND SEX MATCHED Tobacco chewers (no cancer ) 71 RELATIVE RISK = 12.5% GHOSH S. Eur J Surg Oncol, 1996

  8. Pre-malignant conditions n =2275 (97-99) LEUKOPLAKIA - 8.5% (194) SMF -10.8%(245)

  9. Oral Cancers Submucous fibrosis Prevalence of tobacco use among oral submucous fibrosis (OSF) cases Gupta PC et al. National Medical Journal of India; 11(3): 113-116, 1998.

  10. Oral Cancers Submucous fibrosis Relative risk of oral submucous fibrosis by the daily frequency of areca nut use - a case control study from Government Dental College, Nagpur Hazare VK et al. National Medical Journal of India. 11(6): 299, 1998.

  11. Chemoprevention

  12. Chemoprevention- Limitations • Costly • Side effects • Long duration • Lesion return on – stoppage • Exact agents not known (curcumin) Encourage patient to stop habits Oral / Dental Hygiene Good Diet

  13. Gingivo - buccal cancer TREATMENT Early Stage I & II Late Stage III & IV Operable III & IVa In Operable Single modality treatment IV b IV c Combined modality treatment Low GC / Symptomatic Rx • SX • RT Sx + PORT / CT RT Radical RT CT RT Pall CT

  14. Gingivo – buccal cancersGoals of treatment • MAXIMIZING CURE RATES • PRESERVING FUNCTION • COSMESIS • COST EFFECTIVE • EXPEDITING CARE

  15. Gingivobuccal Cancers Factors Affecting Treatment • TUMOR FACTORS • T size, Location to bone, Type of lesion, Nodal disease • PATIENT FACTORS • Performance status, Persistence of habits, Preference • PHYSICIAN FACTORS • Availability of MULTIDISCIPLINARY TEAM & EXPERTISE

  16. GINGIVO – BUCCAL CANCERSEARLY T1/T2 CANCERS SX = RT Cancer of the Oral Cavity – Jatin P. Shah & M J Zelefsky

  17. Radiotherapy Carcinoma Buccal Mucosa 185 cases 2 years DFS - 48% RT 46% SX Early Stage Chaudhary, Seminars in Surgical Oncology 1989

  18. GINGIVO – BUCCAL CANCERSEARLY T1/T2 CANCERS - RT • BOTH EXTERNAL & INTERSTITIAL NEEDED • PROLONGED TREATMENT • SIDE EFFECTS • Xerostomia, Dental caries, ORN. • CAN BE ONLY GIVEN ONCE • Not suited for alveolar lesions “Radiotherapy is chosen when surgery not possible / functional or cosmetic problems are anticipated”

  19. GINGIVO – BUCCAL CANCERSEARLY T1/T2 CANCERS - Surgery • SIMPLE • EXPEDIOUS • NO SIGNIFICANT FUNCTIONAL & COSMETIC DEFECTS • REPEATED PROCEDURE POSSIBLE • COST EFFECTIVE • CHOICE OF TREATMENT

  20. GB Cancers – T1/T2 cancersSurgery ( margins) • WIDE; ADEQUATE MARGINS > 5mm • DEPTH – BUCCINATOR MUSCLE • Sieczka et al ( Roswell Park, Am J Otolaryngol 2001) - 40% local failure T1 – T2 • Post-op ADJUVANT NECESSARY

  21. Gingivo – Buccal Cancers (T1 / T2) M D Anderson Experience Jan 1974 – Dec1998 • Worse than other head & neck cancers stage matched • Bad Prognostic factors – muscle, Stenson duct involvement, ECS Diaz, Head & Neck ; April 2003

  22. GBS Cancers – The TMH Experience (1997-99) Early Stage(I/II) n 207pts Median follow up 2.2 yrs DFS 2yrs 65.7% 5yrs 50.33% Local Rec. rate 21% Salvage rate 37%

  23. GINGIVO – BUCCAL CANCERSEARLY T1/T2 CANCERS – SURG. v/s RT • IS A RANDOMIZED TRIAL FEASIBLE? • NO – IT WOULD BE, • UNETHICAL • DIFFICULT OT ACCRUE PATIENTS

  24. Early GBS Cancers (T1/T2)Management of the Neck • Low propensity to cervical metastasis [ <10% ] • 7.2%Clinically N0 have occult metastasis (Nair, Cancer 1988) • CAN WAIT & WATCH UNLESS • Poor follow up • Cheek flap for surgical access

  25. Marginal Mandibulectomy for GBS Cancers:TMH Experience • Pradhan SA et al Indian J Cancer 1987 Control rate: 79% • Pathak KA et al EJSO 2004 1994-2001 n=83 2-year local control: 79%

  26. Marginal MandibulectomyContraindications • Locoregional control influenced by soft tissue margins(p<0.01)* - 127pts / 94 marginal mandibulectomies O’Brien C.J., Int J Oral Maxillofac Surg 2003

  27. GB Cancers – Locally advancedT3, T4 • SURGERY FOLLOWED BY PORT • RADIOTHERAPY WITH SALVAGE SURGERY • NO RANDOMIZED CONTROL TRIALS

  28. Radiotherapy Carcinoma Buccal Mucosa 185 cases Late Stage 2 years DFS - 5% RT 33% SX Chaudhary, Seminars in Surgical Oncology 1989

  29. Gingivo – Buccal Sulcus TumorsRadiotherapy • 234 patients (Nair et al Cancer 1988) • Stage I – 85%, Stage II – 63%, Stage III – 41%, Stage IV -15% • Radium implant (28) = Small Volume ext. RT (62% Vs 64%) • Dismal Survival with RT in advanced stage poor surgical salvage • Compared three groups : S alone / S – PORT / RT (no survival) • Chhetri D.K., Otolaryngol Head Neck Surg 2000

  30. Adjuvant RT (RTOG 73.03)1973-1979 ( N=277) Pre-op POST OP RT LR CONTROL 48% 65% [p=0.04] SURVIVAL 33% 38% [p=O.1,better trend] COMPLICATIONS SAME ORAL CAVITY (43) PREOP RT PORT SUBSET OAS 30% 36% ANALYSIS LRC 43% 52%

  31. Radiotherapy in head and neck Cancers RTOG 73-03 277 PATIENTS - FOLLOW UP 9-15 yrs PRE OP RT POST OP RT [ 50.0 GY ] [ 60.0 GY ] • LOCO REGIONAL CONTROL BETTER (p = 0.04) • NO DIFFERENCE IN ABSOLUTE SURVIVAL (p = 0.15) • COMPLICATIONS SAME (p - NS)

  32. Surgery + PORT (1988 – 1994) n-57 – ( Sx + RT) RT 45 – 68.4 (61.2 Gy) Poor prognostic factors – (Univariate) - Positive Surgical Margin - Tumor invasion of cheek Poor prognostic factors – (Multivariate) - Tumor invasion of skin (p=0.0014) Fu-min Fang et al Head & Neck 1997

  33. n 624 DFS 2yrs 38.5% 5yrs 13% GBS Cancers – The TMH ExperiencePrognostic factors -Late Stage ( III / IVa) Univariate Analysis Grade p=0.002 Cut margins p=0.04 Node positivity p=0.000 Perinodal extension p=0.008 Thickness > 4mm p=0.004 Multivariate Analysis Node positivity p=0.001, HR=2.81, CI (1.5 – 5.2) Thickness >4mm p=0.002, HR=1.8, CI (1.2 – 2.8)

  34. Surgery v/s Surgery + PORT(1989 – 1993) N=176 patients 115(S) 61(S+R) LR control 11% 48% III/IV (p=0.001) 71% 75% I/II (p=NS) PROGNOSTIC FACTORS • Margins • Thickness • Bone invasion • Grade • Nodal involvement RT BETTER IF BEFORE 30 DAYS - Dixit S, Vyas RK, Ann Surg Oncol. 1998

  35. GB Sulcus Cancers – POST OP RTRCT • 30 MONTHS FOLLOW UP • DISEASE FREE SURVIVAL 38% v/s 68% ( p < 0.005) Mishra et al (1996 – European Journal of Surgical Oncology)

  36. RCT – Role of RT Peters et al (1993) RISK GROUPS RCT N = 240 LOW RISK HIGH RISK DOSE A DOSE B DOSE C 52 – 54 Gy/ 6wks 63Gy/ 7wks/35# 68.4Gy/7.5wks/35# Interim Analysis Higher Recc 57.6Gy/ 6.5wks CONCLUSIONS: • A minimum of 57.6 Gy with boost of 63 Gy to sites of high risk and ECS, is essential • Treatment should be started as soon as possible • Dose escalation above 63 Gy does not appear to improve therapeutic ratio

  37. POST OP RT • RISK FACTORS: • Oral cavity primary • Margins close / positive • Perineural invasion •  2 positive lymph nodes • Largest node > 3 cms • Performance status  2 [WHO] • Delay > 6 weeks (Ang et al, 2001)

  38. Results Low risk / Intermediate risk had similar control & survival • They did better than high risk • High risk had a trend towards better control when RT was given over 5 weeks Ang et al, 2001

  39. POST OP CHEMORADSEORTC – NEJM 2004 • Median follow up 60 months • Progression free survival 47% v/s 36% (p = 0.04) • Overall survival 53% v/s 40% (p = 0.02) • Locoregional recurrences 18% v/s 31% (p = 0.007) • Toxicity [GR3] 41% v/s 21% (p = 0.001)

  40. POST OP CHEMORADSRTOG (9501) – NEJM 2004 • Median follow up 60 months • Locoregional control 82% v/s 72% (p = 0.01) • Disease free survival better (p = 0.04) • Overall survival similar (p = 0.19) • Acute toxicity [GR3] 77% v/s 34% (p < 0.001)

  41. Gingivo – Buccal Cancers (T3 / T4)Prospective Randomised Control Trial • DFS 61% Vs 37% (p=0.01) • Local Recurrence less in first 6 months (p=0.002) Rao et al Am J Surg. 1994

  42. G B Cancers - T 3 / 4Management of nodes 1980 – 1989 - 527 patients Extent of neck SD SOHD RND Dissection (Level I ) (Level I – III) (Level I – V ) N0 N+ N0 N+ N0 N+ Nodes 95 71 141 42 67 111 Regional 11(12%) 24(34%) 7(5%) 8(19%) 2(3%) 20(18%) Recurrence Pradhan S.A., D’Cruz A.K. – Eur Arch Otorhinolaryngol (1995) 252 – 143 - 145

  43. Recurrent Oral Tumors • 38 patients who recurred after curative treatment • Salvage better if :- • i) Initial tumor stage I / II Vs III / IV ( p < 0.001) • ii) Recurring after 6 months ( p < 0.005) • iii) Surgery for salvage Vs RT / CT ( p < 0.001) • iv) Stage of recurrence (N S) • Overall Salvage rate 21% • Overall salvage rate whether 15% (Wheeler, 1990) • Schwatz, Head & Neck, Jan 2000

  44. Management of Advanced Unresectable Head and Neck cancers • Altered fractionation radiation • Induction chemotherapy • Alternating chemo-radiotherapy • Concurrent CT RT

  45. Altered Fractionation RadiationRTOG 9303 N=1113 patients Four arms Standard fractionation Hyperfractionation Accelerated hyperfractionation with Split Accelerated fractionation with Concomitant boost Results Better locoregional control with Hyperfractionation (p=0.045) & Accelerated fractionation with Concomitant boost (p=0.050) All three Altered fractionation group had increased acute toxicity and comparable late toxic effects Fu et al,Int J Radiat Oncol Biol Phys 2000

  46. GB cancers stage- IV B/C No conclusive evidence confirming the role of chemotherapy in palliation as compared to best supportive care

  47. Objectives improvement in quality of life objective tumour response (complete and partial) toxicity, tolerability and safety one-year survival Foscan study in advanced disease

  48. 147 patients assessed to date[ 109 M, 38 F] 50% Caucasians, 50% Asians Clinical benefit 24% objective response 53% overall palliative benefit PDTAdvanced Cancers

  49. Overall study results Palliation ( 122 patients.) Overall palliative benefit 53% (64 patients) 43 patients were optimally treated 61% showed overall palliative benefit

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