xRead - Nasal Obstruction (September 2024) Full Articles

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KUANetal.

TABLE XXV.8 (Continued)

Clinical endpoints

Study

Year LOE Study design Study groups

Conclusion

Chenet al. 1694

1. 2-year FFS 86% in CRT + AC versus 84% in CRT 2. 2-year OS 94% in CRT + AC versus 92% in CRT 3. 2-year DMFS 88% in CRT + AC versus 86% in CRT 4. 2-year LRFS 98% in CRT + AC versus 95% in CRT 5. All not statistically significantly different

1. 2-year FFS 2. 2-year OS, DMFS, and LRFS

2012 2

Phase III RCT 408 patients with stage III/IV NPC (except T3-4N0) CRT versus CRT + AC

Abbreviations: AC, adjuvant chemotherapy; CRT, chemoradiation; DMFS, distant metastasis-free survival; FFS, failure-free survival; IC, induction chemotherapy; LRFS, locoregional failure/recurrence-free survival; NPC, nasopharyngeal carcinoma; OS, overall survival; PFS, progression-free survival; PR, partial response; RT, radiation therapy.

CRT + AC with CRT alone showed no improvement in FFS at 2 years. 1694 The AC regimen studied consisted of 80mg/m 2 adjuvant cisplatin and 800 mg/m 2 per day flu orouracil for 120 h every 4 weeks for three cycles. Other agents have also been studied in prospective trials and therefore comparing the use of various agents in dif ferent stages of disease is difficult. The use of network meta-analysis partly solves this problem. Most network meta-analysis failed to show any improvement in sur vival with AC. 1695–1697 A recent phase III RCT using oral chemotherapy capecitabine for 1 year (oral metronomic capecitabine 650 mg/m 2 body surface area twice daily or 1 year) did show improvement in OS and both locore gional and DMFS. 1698 The other advantage of the oral drug is the tolerability and minimal deterioration in QOL dur ing treatment. Further studies are needed to confirm the benefits of this treatment approach. Role of adjuvant chemotherapy in treatment of NPC

Benefits–harm assessment

Balance of benefits and harms.

Value

AC with oral capecitabine may be beneficial but need to await further clinical trials to confirm. Cisplatin-based AC does not show any benefit across multiple trials. For these reasons, routine AC with cisplatin agents is not recommended as there is potential for severe toxicities and minimal survival benefits.

judgments

Policy level Option. Intervention Adjuvant chemotherapy with oral capecitabine can be considered in

advanced-stage NPC. Consider recruitment of patients with advance-stage NPC that have completed definitive CRT to clinical trials for adjuvant chemotherapy with newer agents.

12 Treatment for metastatic disease Systemic dissemination is one of the major reasons for treatment failure in NPC. Platinum-based chemotherapy has been the standard first-line treatment for metastatic NPC (Table XXV.9). 1699 A systematic review from 56 stud ies showed that combination treatment regimen with platinum-based chemotherapy significantly improved PFS compared with monotherapy, despite the increased occur rence of grade 3 and 4 hematological toxicities. 1700 A meta-analysis evaluating the efficacy of the commonly used first-line chemotherapy regimens in metastatic dis ease showed that combination of taxane plus platinum resulted in the highest 1-year OS rate of 79% and dis ease control rate (DCR) of 92%. 1701 Triplet combination offered the best short-term efficacy in that meta-analysis; however, it failed to improve prognosis and was associ ated with intolerable higher incidence of adverse effects.

Aggregate grade of evidence

A (Level 1: three studies; Level 2: two studies)

Benefit

Adjuvant chemotherapy with oral metronomic capecitabine 650 mg/m 2 body surface area twice daily for 1 year showed improvement in OS, LRFS, and DMFS at 3years. Network meta-analysis showed no benefit of AC with cisplatin agents. Severe toxicities with adjuvant cisplatin chemotherapy due to prior treatment with platinum-based regimen. Cost comparison analyses have not been undertaken.

Harm

Cost

(Continued)