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KUANetal.

TABLE XXV.7 (Continued)

Clinical endpoints

Study

Year LOE Study design Study groups

Conclusion

Zhang et al. 1691

1. IC + CRT group had

1. 3-year RFS 2. OS, DRFS, LRRFS

480 patients with stage III to IVB NPC of WHO type II or III IC + CRT versus CRT alone 479 patients with stage IVA or IVB (AJCC 5th edition) NPC from 11 institutions IC + CRTversus CRTalone

2019 2

Multicenter phase III RCT

significantly improved 3-year RFS and OS compared with CRT alone group 2. IC + CRT had better 3-year DRFS, but not LRFS, than CRT alone group 1. Significantly higher DFS in IC + CRT arm than in CRT arm after stratifying for N3b disease and LDH; no significant difference in DMFS and OS 2. IC + CRT arm had significantly higher rate of grade 3 or 4 toxicities 3. The overall response and CR rate were higher in ICRT arm

Honget al. 1689

2018 2

Phase III RCT (TCOG 1303)

1. 5-year DFS 2. CRandPR 3. DFFS and OS

Abbreviations: AE, adverse event; CR, complete response; DMFS, distant metastasis-free survival; EORTC-QLQ-C30, European Organization for Research and Treatment of Cancer Core QOL Questionnaire; EORTC-QLQ-H&N35, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire in Head and Neck Cancer; FFS, failure-free survival; IC, induction chemotherapy; LRFS, locoregional failure/recurrence-free survival; NPC, nasopharyngeal carcinoma; OS, overall survival; PF, cisplatin, 5-fluorouracil; PFS, progression-free survival; PR, partial response; TPF, docetaxel, cisplatin, 5-fluorouracil.

80 mg/m 2 on day 1, every 3 weeks for three cycles fol lowed by CRT with every 3-week cisplatin versus CRT with 3 weekly cisplatin alone. The results showed that IC + CRT resulted in improved OS, RFS, and DMFS but not LRFS at 3 years after treatment. The HR for OS in the IC + CRT group is 0.43. 1691 A network meta-analysis comparing different IC regimens showed that gemcitabine and cisplatin (GP) combination IC has the greatest ben efit in OS with manageable toxicities. TPF came second in terms of improvement in OS and highest in terms of LRFS but also had the highest rate of grade 3 and 4 adverse effects. 1692 A unique RCT evaluating the QOL of IC + CRT versus CRT alone found that the IC arm seems to have superior long-term QOL in both the global scores and specific head and neck QOL scores, presum ably due to the lower dose to critical normal structures spared by IC. The study, however, did not compare the acute toxicities in the IC + CRT group versus the CRT alone group. 1693 Role of induction chemotherapy in treatment of NPC

Harm

Use of IC increases grade 3 and 4 adverse events with TPF having the highest number of adverse events. However, long-term QOL may be similar or even better than CRT alone. Cost comparison analyses have not been undertaken. Preponderance of benefits over harms. For patients with high performance status and minimal co-morbidity, IC would improve the survival. However, IC increases the toxicity of treatment and may not be tolerated by patients with less-than-optimal performance status or comorbidities. Nevertheless, IC with GC regimen has survival benefits that justify the increased cost and toxicity during treatment.

Cost

Benefits–harm assessment

Value

judgments

Policy level Strong recommendation. Intervention IC with GP or TPF, for three cycles before definitive CRT, should be considered for

advanced-stage NPC (stage III–IVB, excluding T3N0) in patients who can tolerate the treatment.

Aggregate grade of evidence

A (Level 1: one study; Level 2: five studies)

Benefit

Induction chemotherapy improves most survival parameters, with GP for three cycles having the best OS followed by TPF.

11 Role of adjuvant chemotherapy In the modern era, the majority of NPC failures are dis tant failures as IMRT and CRT provide excellent LRC.

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