Editor's Note
On the first day of the 2021 CSCO Guidelines Meeting, Professor Fang Wenfeng of the Sun Yat-sen University Cancer Center brought you the 2021 update of the advanced nasopharyngeal cancer guidelines. He introduced in detail the research basis for promoting the update of the guidelines and looked forward to the future development vision of the nasopharyngeal cancer field in my country.
Professor Fang Wenfeng
1 Main points of the 2021 version of the nasopharyngeal cancer guideline update
1. First-line treatment update
(1) Added a new recommendation of "local radiotherapy consolidation after cisplatin + 5FU", Class 1A evidence
On February 2, 2021, the American Society of Clinical Oncology (ASCO) released its annual tumor progress annual report , which emphasized the most important clinical research progress in the past year. The team of Professor Chen Mingyuan from the Sun Yat-sen University Cancer Center was successfully selected for the "Phase III clinical study of local radiotherapy for newly diagnosed distant metastatic nasopharyngeal carcinoma" published in JAMA Oncology, the top international oncology journal, on July 23, 2020. Research results show that both chemotherapy + local radiotherapy can significantly improve PFS/OS. This study is the first comparative study of local radiotherapy + chemotherapy and chemotherapy alone, and the safety of combined local and regional radiotherapy after chemotherapy is controllable. This trial confirmed the status of local radiotherapy in the treatment of nasopharyngeal carcinoma and was included in the guidelines as Class IA evidence.
(2) Added a new level III recommendation of "cisplatin + gemcitabine + Endo", category 2B evidence.
The results of a phase II clinical trial initiated by Professor Chen Xiaozhong showed that the mPFS of Endo+cisplatin+gemcitabine in the treatment of metastatic nasopharyngeal carcinoma was 19.4 months, the 1-year OS was 90.2%, the ORR was 85.7% (95% CI, 66.4–95.3%), and the CR rate was 50%.
2. Second-line treatment update
(1) Added conditions for chemotherapy application: "If the first-line drug is not received";
(2) Added "encourage patients to participate in clinical trials" as a level I recommendation;
(3) Added "toripalimab" as a level III recommendation, type 2B evidence;
Single-arm, open, II initiated by Professor Xu Ruihua of Sun Yat-sen University Cancer Center In the phase 1 clinical trial , patients with recurrent/metastatic nasopharyngeal carcinoma who had previously received at least first-line chemotherapy were treated with toripalimab 3 mg/kg, Q2W, and the results showed ORR in the entire population. 20.5%, and the ORR of third-line and above treatment is 23.9%. The mPFS of the whole population was 1.9 months, the mPFS of the third-line and above treatment was 2.0 months, the mOS of the whole population was 17.4 months, and the mOS of the third-line and above treatment was 15.1 months.
(4) adds the application conditions of "pembrolizumab": "Limit PD-L1 TPS ≥ 1%";
(5) adds the application conditions of immunotherapy : "if the first line has not received PD-1/PD-L1 inhibitors".
3. Third-line and above treatment updated
(1) added recommended classification for third-line and above treatment;
(2) added "toripalimab" as a level I recommendation, type 2A evidence;
research evidence is the same as second-line treatment (3), 48.4% of patients in the trial received third-line or above treatment, and the ORR for third-line and above treatment 23.9%, and the median OS was 15.1 months. The National Medical Products Administration (NMPA) approved toripalimab for the treatment of patients with recurrent/metastatic nasopharyngeal carcinoma who have failed second-line or above systemic treatments.
(3) Added "camrelizumab" as a Class I recommendation, Class 2A evidence;
A single-arm, open, single-center, phase II clinical trial initiated by Professor Li Li of the Sun Yat-sen University Cancer Center used the anti-PD-1 monoclonal antibody camrelizumab to treat recurrent/metastatic nasopharyngeal carcinoma after failure of second-line or above chemotherapy. The results showed that: camrelizumab was used in the treatment of recurrent/metastatic nasopharyngeal carcinoma in third-line or above, ORR 28.2%, mPFS 3.7 months, mOS 17.1 months, and the incidence of TRAEs grade 3 and above was 14.7%. The research results were announced in the form of an oral report at ESMO 2020.
(4) adds “encouraging patients to participate in clinical trials” as a Level I recommendation.
4. Summary of treatment data for recurrent and metastatic nasopharyngeal carcinoma
In the first-line treatment, the ORR of GP alone reaches 64%, and the ORR of GP+enduumab reaches 86%; the ORR of GP+carrelizumab reaches 91%; in the second-line treatment, the ORR of monotherapy reaches 20%-40%; in the third-line treatment, the ORR of caripalimab reaches 28.2%.
2 Future prospects of comprehensive treatment of advanced nasopharyngeal carcinoma
1.CAPTAIN-1ST: Camrelizumab combined with GP (Phase III clinical study of first-line treatment of recurrent/metastatic nasopharyngeal carcinoma)
The CAPTAIN-1ST study initiated by Professor Li Li from Sun Yat-sen University Cancer Center: Using anti-PD- 1. The monoclonal antibody camrelizumab + GP is a first-line treatment for recurrent/metastatic nasopharyngeal carcinoma. It has reached the primary endpoint - progression-free survival (PFS) evaluated by the Independent Imaging Review Committee (IRC). It was included in the priority review by NMPA in early November 2020. On-site verification has been completed in March 2021. It is expected to be approved for indications in June 2021. The data will be announced at the ASCO conference in early June 2021.
2.JUPITER-02: Toripalimab combined with GP (Phase III clinical study for first-line treatment of recurrent/metastatic nasopharyngeal carcinoma)
The JUPITER-02 study initiated by Professor Xu Ruihua from Sun Yat-sen University Cancer Center: anti-PD-1 monoclonal antibody toripalimab + GP as first-line treatment of recurrent/metastatic nasopharyngeal carcinoma has reached the primary endpoint (PFS assessed by IRC). NPMA will accept marketing applications for indications on February 18, 2021, and is expected to be approved in 2022.
3.RATIONALE-309: Tislelizumab combined with GP (Phase III clinical study of first-line treatment of recurrent/metastatic nasopharyngeal carcinoma)
The RATIONALE-309 study initiated by Professor Li Li from Sun Yat-sen University Cancer Center: anti-PD-1 monoclonal antibody tislelizumab + GP as first-line treatment of recurrent/metastatic nasopharyngeal carcinoma has completed enrollment.
4.AK105-202: Anti-PD-1 monoclonal antibody AK105 (Phase II clinical study of third-line and above treatment of metastatic nasopharyngeal carcinoma)
Fudan University Cancer Hospital The AK105-202 study initiated by Professor Hu Chaosu has reached the primary endpoint ORR. This study is a single-arm, open-label, multi-center, phase II study: evaluating the efficacy and safety of the anti-PD-1 monoclonal antibody AK105 in patients with metastatic nasopharyngeal carcinoma who have failed at least two lines of chemotherapy. It is currently applying for indications. If approved, it will be the third PD-1 monoclonal antibody for third-line or above treatment.
Expert Profile
Fang Wenfeng Professor
Chief Physician, Sun Yat-sen University Affiliated Cancer Hospital, Doctoral Supervisor
Member of CSCO Professional Committee on Non-Small Cell Lung Cancer
Member of CSCO Professional Committee on Nasopharyngeal Cancer
Guangdong Anti-Cancer AssociationDeputy Chairman of the Professional Youth Committee for Nasopharyngeal Cancer
Deputy Chairman of the Precision Medicine and Molecular Diagnosis Professional Committee of the Guangdong Provincial Medical Association
Deputy Chairman of the Genetics Special Committee of the Guangdong Provincial Society of Chest Diseases
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