ESMO Voice of China Exploration of the application of raltitrexed plus bevacizumab in the second-line treatment of mCRC patients

The 2022 European Society for Internal Oncology (ESMO) Annual Meeting was held
in Paris from September 9 to 13 local time.

As Europe's most prestigious and influential oncology conference, ESMO Annual Conference covers basic research, translational research and the latest clinical research advances, and will provide a broad and excellent academic platform
for clinical practice, multidisciplinary discussion, etc.

Chemotherapy remains one of the most important treatment options for patients with metastatic colorectal cancer (mCRC), and as the cornerstone of systemic therapy for patients with mCRC, the exploration of chemotherapy strategies is still ongoing
.

At this conference, Professor Li Sheng of Jiangsu Provincial Cancer Hospital published a Phase II study to explore the application of raltitrexed plus bevacizumab in the second-line treatment of mCRC patients in China
.

For patients with mCRC who have failed fluoropyrimidine-based first-line chemotherapy, the options for follow-up therapy are limited
.

Studies suggest that chemotherapy based on ratitircet may be one of the follow-up treatment options for patients with mCRC; Other studies have shown that the combination of standardized chemotherapy regimens in combination with bevacizumab improves the survival benefit
of patients.

Therefore, the investigators designed this Phase II trial to evaluate the efficacy and safety
of ratititrexed plus bevacizumab in second-line therapy in mCRC patients in China.

This is a prospective, open-label, multicenter Phase II clinical trial in which patients were assigned to receive BEV+SALIRI (bevacizumab 7.
5 mg/kg d1, raltitrexed 3 mg/m² d1, irinotecan 200 mg/m² d1; q3w) or BEV+SALOX (bevacizumab 7.
5 mg/kg d1, raltetricet 3 mg/m² d1, oxaliplatin 130 mg/m² d1; q3w) regimen for treatment (Figure 1
).

Efficacy assessment after 6 cycles of treatment, and maintenance therapy is received in patients with SD or better disease response (bevacizumab 7.
5 mg/kg d1, raltetraxed 3 mg/m² d1; q3w), until disease progression or toxicity is intolerable
.

The primary endpoints of the study were progression-free survival (PFS), and secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), quality of life (QOL), and safety
.

Figure 1 Study design

Between December 2016 and October 2021, a total of 100 patients were enrolled in the study, of which 94 patients received the BEV+SALIRI regimen and 6 patients received the BEV+SALOX regimen
.

A total of 807 cycles of treatment were completed, of which 31 patients received maintenance therapy
.

Patient baseline features are shown in
Table 1.

Table 1 Patient baseline features

The results showed that the patient's ORR was 26% and the DCR was 87%.


A total of 81 patients reached the primary study endpoint, as shown in Figure 2, with a median PFS of 7.
3 months (95% CI: 5.
1 to 9.
4), and the median OS was not reached
.

Figure 2 Patient PFS

Safety analysis showed that the adverse events (AEs) that occurred in patients were mostly grade 1/2, and no serious adverse events (SAE)
occurred.

The specific occurrence of AE is shown in Table 3, and the overall tolerability of the treatment regimen is good
.

Table 3 Adverse events

For patients with mCRC, bevacizumab plus a second-line regimen based on raltitrexed performs well in PFS, ORR, and DCR and is safe and controlled
.

This protocol may become one of the options for second-line treatment of mCRC patients in China, and the researchers believe that this protocol is worthy of further exploration and evaluation
.

References

1.
 Sheng Li, et al.
Preliminary results of bevacizumab plus raltitrexed-based chemotherapy as second-line therapy in patients with metastatic colorectal cancer (mCRC): A multicenter phase II trial.
409P 2022 ESMO Congress.

Reviewer: Traveler

Typesetting: Youshi

Execution: Small Garden