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![TAX 324
Median follow-up was 72·2 months (95% CI 68·8–75·5).
Overall survival was significantly better after treatment with TPF
versus PF (hazard ratio [HR] 0·74, 95% CI 0·58–0·94), with an
estimated 5-year survival of 52% in patients treated with TPF and
42% in those receiving PF.
Median survival was 70·6 months (95% CI 49·0–89·0) in the TPF
group versus 34·8 months (22·6–48·0) in the PF group (p=0·014).](https://image.slidesharecdn.com/jc210418-180421170254/75/NACT-in-Head-and-Neck-cancer-16-2048.jpg)
![ZHONG
After a median follow-up of 30 months, there was no
significant difference in OS (hazard ratio [HR], 0.977;
95% CI, 0.634 to 1.507; P .918) or disease-free survival
(HR, 0.974; 95% CI, 0.654 to 1.45; P .897) between
patients treated with and without TPF induction.](https://image.slidesharecdn.com/jc210418-180421170254/75/NACT-in-Head-and-Neck-cancer-37-2048.jpg)
![RTOG
Both chemotherapy regimens significantly improved LFS
compared with RT alone (induction chemotherapy v RT alone:
hazard ratio [HR], 0.75; 95% CI, 0.59 to 0.95; P .02;
concomitant chemotherapy v RT alone: HR, 0.78; 95% CI, 0.78
to 0.98; P .03).
Overall survival did not differ significantly, although there was
a possibility of worse outcome with concomitant relative to
induction chemotherapy (HR, 1.25; 95% CI, 0.98 to 1.61; P .08).](https://image.slidesharecdn.com/jc210418-180421170254/75/NACT-in-Head-and-Neck-cancer-47-2048.jpg)
Uploaded byAjay Manickam
NACT in Head and Neck cancer
This document discusses neoadjuvant chemotherapy in head and neck cancer. It provides background on when neoadjuvant chemotherapy is given, what regimens are used, and evidence from studies comparing neoadjuvant chemotherapy plus radiation/surgery versus radiation/surgery alone. Several large studies found that adding docetaxel, cisplatin and fluorouracil as neoadjuvant chemotherapy improved overall and progression-free survival compared to cisplatin and fluorouracil alone. However, other studies found no difference in outcomes between neoadjuvant chemotherapy followed by chemoradiation versus chemoradiation alone. Concomitant chemoradiation appears superior to induction chemotherapy for larynx preservation.
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NACT in Head and Neck cancer
- 1. NEOADJUVANT CT INHEAD AND NECK CANCER Dr AJAY MANICKAM MS, DNB Fellow Head and Neck Oncology Tata Medical center
- 2. NEO ADJUVANT CHEMOTHERAPY Neo(adjuvant – in addition to) chemotherapy the drugs may shrink the tumor and give more surgical options.
- 3. BACKGROUND WHEN TO GIVENACT (HEAD AND NECK ) WHAT REGIMEN NACT + CRT / CRT - LEVEL OF EVIDENCE NACT + SURGERY / SURGERY + STD RT/CRT (ORAL CAVITY) NACT IN ORGAN PRESERVATION
- 4. When ? • RESECTABLEORAL CAVITY TUMOURS NACT • NON RESECTABLE ORAL TUMOURS NACT
- 5. NACT IN RESECTABLETUMOURS ITALY
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- 10. CONCLUSION This studycould not prove a favorable effect on long-term local control of disease and survival by the addition of primary chemotherapy to a multidisciplinary strategy comprising primary surgery and postoperative radiotherapy.
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- 12. WHAT ? TAX323 TAX 324
- 13. TAX 323 A totalof 358 patients underwent randomization, with 177 assigned to the TPF group and 181 to the PF group. At a median follow-up of 32.5 months, the median progression-free survival was 11.0 months in the TPF group and 8.2 months in the PF group (hazard ratio for disease progression or death in the TPF group, 0.72; P=0.007). Treatment with TPF resulted in a reduction in the risk of death of 27% (P=0.02), with a median overall survival of 18.8 months, as compared with 14.5 months in the PF group.
- 14. TAX 323 There weremore grade 3 or 4 events of leukopenia and neutropenia in the TPF group and more grade 3 or 4 events of thrombocytopenia, nausea, vomiting, stomatitis, and hearing loss in the PF group. The rates of death from toxic effects were 2.3% in the TPF group and 5.5% in the PF group. Addition of docetaxel significantly improved progression- free and overall survival in patients with un-resectable squamous- cell carcinoma of the head and neck.
- 15. TAX 324 METHODS TAX324 was a randomised, open-label phase 3 trial comparing - three cycles of TPF induction chemotherapy 1 1) Docetaxel 75 mg/m2, followed by 2) Intravenous cisplatin 100 mg/m2 and 3) Fluorouracil 1000 mg/m2 per day, (administered as a continuous 24-h infusion for 4 days) with three cycles of PF 1) Intravenous cisplatin 100 mg/m2, followed by 2) Fluorouracil 1000 mg/m2 per day as a continuous 24-h infusion for 5 days) in patients with stage III or IV squamous- cell carcinoma of the head or neck.
- 16. TAX 324 Median follow-upwas 72·2 months (95% CI 68·8–75·5). Overall survival was significantly better after treatment with TPF versus PF (hazard ratio [HR] 0·74, 95% CI 0·58–0·94), with an estimated 5-year survival of 52% in patients treated with TPF and 42% in those receiving PF. Median survival was 70·6 months (95% CI 49·0–89·0) in the TPF group versus 34·8 months (22·6–48·0) in the PF group (p=0·014).
- 17. TAX 324 Progression-free survivalwas also significantly better in patients treated with TPF (median 38·1 months, 95% CI 19·3–66·1, vs 13·2 months, 10·6–20·7; HR 0·75, 95% CI 0·60–0·94). No significant difference in dependence on gastric feeding tubes and tracheostomies between treatment groups. In the TPF group, three (3%) of 91 patients remained feeding- tube dependent, compared with eight (11%) of 71 patients in the PF group. Six (7%) of 92 patients had tracheostomies in the TPF group, versus eight (11%) of 71 in the PF group.
- 18. NACT + CRTVS CRT NEOADJUVANT CT FOLLOWED BY CRT VS CRT PARADIGM DECIDE TTCC
- 19. PARADIGM Patients wereeligible if their tumour was either unresectable or of low surgical curability on the basis of advanced tumour stage (3 or 4) or regional-node stage (2 or 3, except T1N2), or if they were a candidate for organ preservation.
- 20. PARADIGM Between Aug 24,2004, and Dec 29, 2008, we enrolled 145 patients across 16 sites. After a median follow-up of 49 months (IQR 39–63), 41 patients had died—20 in the induction chemotherapy followed by chemoradiotherapy group and 21 in the chemoradiotherapy alone group.
- 21. PARADIGM 3-year overall survivalwas 73% (95% CI 60–82) in the induction therapy followed by chemoradiotherapy group and 78% (66–86) in the chemoradiotherapy alone group (hazard ratio 1·09, 95% CI 0·59–2·03; p=0·77). More patients had febrile neutropenia in the induction chemotherapy followed by chemoradiotherapy group (16 patients) than in the chemoradiotherapy alone group (one patient).
- 22. PARADIGM CONCLUSION Although survivalresults were good in both groups there was no difference noted between those patients treated with induction chemotherapy followed by chemoradiotherapy and those who received chemoradiotherapy alone.
- 23. DECIDE Treatment-naive patientswith nonmetastatic N2 or N3 SCCHN were randomly assigned to CRT alone (CRT arm; docetaxel, fluorouracil, and hydroxyurea plus radiotherapy 0.15 Gy twice per day every other week) versus two 21-day cycles of IC (docetaxel 75 mg/m2 on day 1, cisplatin 75 mg/m2 on day 1, and fluorouracil 750 mg/m2 on days 1 to 5) followed by the same CRT regimen (IC CRT arm).
- 24. DECIDE Serious adverse eventswere more common in the IC arm (47% v 28%; P .002). With a minimum follow-up of 30 months, there were no statistically significant differences in OS (hazard ratio, 0.91; 95% CI, 0.59 to 1.41), RFS, or DF-free survival. Conclusion IC did not translate into improved OS compared with CRT alone
- 25. TTCC Overall, this trialfailed to show any advantage of ICT-CCRT over CCRT alone in patients with unresectable LASCCHN
- 26. METAANALYSIS Five randomized trialsrepresenting 1,772 patients were identified. Updated individual patient data (IPD) were retrieved for all trials. The log-rank test, stratified by trial, was used for comparison. Interaction or trend tests were used to study the interaction between covariates and treatment.
- 27. FOREST PLOT OSAND LRF
- 28. CONCLUSION Although induction Tax-PFis superior to PF in terms of OS, PFS, and loco-regional and distant control, its precise role compared with upfront CRT in the management of loco-regionally advanced HNSCC remains to be defined.
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- 31. BUDACH Additional induction CHXwith TPF before RT-CHX did neither result in a significant improvement of OS (Hazard Ratio: 1.010, 95% confidence limits (CL) 0.84–1.21, p = 0.92), nor in a statistically significant benefit of PFS (Hazard Ratio: 0.91, 95% CL 0.75–1.1, p = 0.32). Conclusion: Additional induction CHX with TPF before RT- CHX does not improve OS and PFS in locally advanced HNSCC compared to definite RT-CHX.
- 32. NACT + SURGERYVS SURGERY
- 33. ZHONG A prospectiveopen-label phase III trial was conducted. Eligibility criteria included untreated stage III or IVA locally advanced resectable OSCC. Patients received two cycles of TPF induction chemotherapy (docetaxel 75 mg/m2 on day 1, cisplatin 75 mg/m2 on day 1, and fluorouracil 750 mg/m2 on days 1 to 5) followed by radical surgery and postoperative radiotherapy (54 to 66 Gy) versus up-front radical surgery and postoperative radiotherapy.
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- 37. ZHONG After a medianfollow-up of 30 months, there was no significant difference in OS (hazard ratio [HR], 0.977; 95% CI, 0.634 to 1.507; P .918) or disease-free survival (HR, 0.974; 95% CI, 0.654 to 1.45; P .897) between patients treated with and without TPF induction.
- 38. LARYNX - GORTECAND RTOG
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- 40. GORTEC Operable patientswith untreated stage III or IV larynx or hypopharynx invasive squamous cell carcinoma who required total laryngectomy were randomly assigned to three cycles of induction chemotherapy with either TPF or PF, followed by radiation therapy for responders
- 41. GORTEC 213 Pts weretreated with median follow-up of 105 months. The 5 and 10-year larynx preservation rates were 74.0% (95% CI = 0.64 to 0.82) vs 58.1% (95% CI = 0.47 to 0.68) and 70.3% (95% CI = 0.58 to 0.8) vs 46.5% (95% CI = 0.31 to 0.63, P = .01) in the TPF vs PF arm, respectively. The 5 and 10-year LDFFS rates were 67.2% (95% CI = 0.57 to 0.76) vs 46.5% (95% CI = 0.36 to 0.57) and 63.7% (95% CI = 0.52 to 0.74) vs 37.2% (95% CI = 0.24 to 0.52, P = .001), respectively.
- 42. GORTEC Long-term follow-up confirmsthat induction chemotherapy with TPF increased larynx preservation and larynx dysfunction–free survival.
- 43. RTOG 91 11 Patientswith stage III or IV glottic or supraglottic squamous cell cancer were randomly assigned to induction cisplatin/fluorouracil (PF) followed by RT (control arm), concomitant cisplatin/RT, or RT alone.
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- 47. RTOG Both chemotherapy regimenssignificantly improved LFS compared with RT alone (induction chemotherapy v RT alone: hazard ratio [HR], 0.75; 95% CI, 0.59 to 0.95; P .02; concomitant chemotherapy v RT alone: HR, 0.78; 95% CI, 0.78 to 0.98; P .03). Overall survival did not differ significantly, although there was a possibility of worse outcome with concomitant relative to induction chemotherapy (HR, 1.25; 95% CI, 0.98 to 1.61; P .08).
- 48. RTOG Concomitant cisplatin/RT significantlyimproved the larynx preservation rate over induction PF followed by RT (HR, 0.58; 95% CI, 0.37 to 0.89; P .0050) and over RT alone (P .001), whereas induction PF followed by RT was not better than treatment with RT alone (HR, 1.26; 95% CI, 0.88 to 1.82; P .35).
- 49. RTOG CONCLUSION These 10-yearresults show that induction PF followed by RT and concomitant cisplatin/RT show similar efficacy for the composite end point of LFS. Loco-regional control and larynx preservation were significantly improved with concomitant cisplatin/RT compared with the induction arm or RT alone
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- 51. MACH - NC Boththe indirect and the direct comparisons were consistent on survival, event-free survival and loco-regional failure, showing a clear advantage in favour of concomitant chemotherapy. The 5 year survival rates in the control arm were, respectively, 27% and 30% in concomitant and induction trials.
- 52. MACH NC concomitantchemotherapy had a pronounced effect on loco-regional failure, which was not observed for induction chemotherapy. Induction chemotherapy provided a relatively more pronounced effect on distant metastases, compared to concomitant chemotherapy, suggesting the need to use a relatively high dose of chemotherapy to influence the occurrence of distant metastases.
- 53. WHEN TO GIVENACT (HEAD AND NECK ) WHAT REGIMEN NACT + CRT / CRT - LEVEL OF EVIDENCE NACT + SURGERY / SURGERY + STD RT/CRT (ORAL CAVITY) NACT IN ORGAN PRESERVATION THANK YOU