Phase II Study of Panitumumab Monotherapy in Chemotherapy-Naïve Frail or Elderly Patients with Unresectable <i>RAS</i> Wild-Type Colorectal Cancer: OGSG 1602

Terazawa, Tetsuji; Kato, Takeshi; Goto, Masahiro; Ohta, Katsuya; Noura, Shingo; Satake, Hironaga; Kagawa, Yutaka; Kawakami, Hisato; Hasegawa, Hiroko; Yanagihara, Kazuhiro; Shingai, Tatsushi; Nakata, Ken; Kotaka, Masahito; Hiraki, Masayuki; Konishi, Ken; Nakae, Shiro; Sakai, Daisuke; Kurokawa, Yukinori; Shimokawa, Toshio; Satoh, Taroh

doi:10.1002/onco.13523

Cited by 11 publications

(16 citation statements)

References 20 publications

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“…The TRAE profile of SCT200 was similar to that of other anti-EGFR monoclonal antibody therapies, such as cetuximab 31,32 , nimotuzumab 33 , and panitumumab [34][35][36] , for solid cancers. All TRAEs were predictable and manageable.…”

Section: Discussionmentioning

confidence: 67%

Safety and efficacy of anti-EGFR monoclonal antibody (SCT200) as second-line therapy in advanced esophageal squamous cell carcinoma

Bai

2022

Cancer Biol Med

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Objective: The mainstay treatment of esophageal squamous cell carcinoma (ESCC) involves chemotherapy and immunotherapy.However, alternative therapies are required for patients who are refractory or intolerant to existing therapies. Methods: In this single-arm, multicenter, open-label phase Ib study, 30 patients received an intravenous infusion of SCT200, an antiepidermalgrowth factor receptor (EGFR) monoclonal antibody, 6.0 mg/kg once a week for 6 weeks, followed by 8.0 mg/kg once every2 weeks until disease progression or intolerable toxicity. The primary endpoint was the objective response rate (ORR). The secondaryendpoints were progression-free survival (PFS), overall survival (OS), and safety. Results: Thirty patients were enrolled between July 2018 and May 2019. The ORR was 16.7% (95% CI: 5.6%–34.7%). The medianPFS and OS were 3.1 months (95% CI: 1.5–4.3) and 6.8 months (95% CI: 4.7–10.1), respectively. A numerical difference without anystatistical significance in ORR was observed in patients with different EGFR expressions (= 50%: 25.0% vs. < 50%: 0%, P = 0.140)or TP53 mutation abundance (< 10%: 23.8% vs. = 10%: 0%, P = 0.286). Improved median PFS (3.4 vs. 1.4 months, P = 0.006) andOS (8.0 vs. 4.2 months, P = 0.027) were associated with TP53 mutation abundance of < 10%. The most common treatment-relatedadverse events of grade 3 or 4 (occurring in = 2 patients) were hypomagnesemia [7 (23.3%)] and rash [2 (6.7%)]. No treatmentrelateddeath occurred. Conclusions: SCT200 monotherapy as the second- or further-line treatment for advanced ESCC showed favorable efficacy, with anacceptable safety profile. TP53 mutation abundance might serve as a potential predictive biomarker.

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Section: Discussionmentioning

confidence: 67%

Safety and efficacy of anti-EGFR monoclonal antibody (SCT200) as second-line therapy in advanced esophageal squamous cell carcinoma

Bai

2022

Cancer Biol Med

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“…The Asian experts also accepted ‘recommendation 4l’ ( Table 1 ) unchanged ( 100% consensus ), supported by data from the Japanese phase II OGSG 1602 study (UMIN000024528) of panitumumab monotherapy in chemotherapy-naive frail/elderly patients with unresectable RAS wt metastatic/advanced CRC. 101 The LoE however, was revised to III , C ( Table 1 ).…”

Section: Resultsmentioning

confidence: 99%

Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with metastatic colorectal cancer

Yoshino,

Cervantes,

Bando

et al. 2023

ESMO Open

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“…It is also possible that even if patients had Grade ≥ 3 CIN and could have continued panitumumab monotherapy while suspending FTD/TPI due to Grade ≥ 3 CIN, investigators may have decided to simply suspend both treatments; this would account for the low panitumumab RDI. Recently, it was reported that in heavily pre-treated patients (refractory to chemotherapy, anti-VEGF, and anti-EGFR therapy [for tumours with wild-type RAS ]) biweekly administration of FTD/TPI with bevacizumab showed promising anti-tumour activity with acceptable toxicity and dramatically decreased CIN compared with the standard combination treatment schedule [ 20 ]. Thus, if panitumumab was combined with biweekly FTD/TPI, it may be possible to decrease CIN and maintain the RDI of both drugs, although additional studies are required to explore this possibility.…”

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of panitumumab in combination with trifluridine/tipiracil for pre-treated patients with unresectable, metastatic colorectal cancer with wild-type RAS: The phase 1/2 APOLLON study

et al. 2021

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Background We aimed to assess the safety and efficacy of combination treatment with panitumumab plus trifluridine/tipiracil (FTD/TPI) in patients with wild-type RAS metastatic colorectal cancer (mCRC) who were refractory/intolerant to standard therapies other than anti-epidermal growth factor receptor therapy. Methods APOLLON was an open-label, multicentre, phase 1/2 trial. In the phase 1 part, 3 + 3 de-escalation design was used to investigate the recommended phase 2 dose (RP2D); all patients in the phase 2 part received the RP2D. The primary endpoint was investigator-assessed progression-free survival (PFS) rate at 6 months. Secondary endpoints included PFS, overall survival (OS), overall response rate (ORR), disease control rate (DCR), time to treatment failure (TTF), and safety. Results Fifty-six patients were enrolled (phase 1, n = 7; phase 2, n = 49) at 25 Japanese centres. No dose-limiting toxicities were observed in patients receiving panitumumab (6 mg/kg every 2 weeks) plus FTD/TPI (35 mg/m2 twice daily; days 1–5 and 8–12 in a 28-day cycle), which became RP2D. PFS rate at 6 months was 33.3% (90% confidence interval [CI] 22.8–45.3). Median PFS, OS, ORR, DCR, and TTF were 5.8 months (95% CI 4.5–6.5), 14.1 months (95% CI 12.2–19.3), 37.0% (95% CI 24.3–51.3), 81.5% (95% CI 68.6–90.8), and 5.8 months (95% CI 4.29–6.21), respectively. Neutrophil count decreased (47.3%) was the most common Grade 3/4 treatment-emergent adverse event. No treatment-related deaths occurred. Conclusion Panitumumab plus FTD/TPI exhibited favourable anti-tumour activity with a manageable safety profile and may be a therapeutic option for pre-treated mCRC patients.

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Phase II Study of Panitumumab Monotherapy in Chemotherapy-Naïve Frail or Elderly Patients with Unresectable RAS Wild-Type Colorectal Cancer: OGSG 1602

Cited by 11 publications

References 20 publications

Safety and efficacy of anti-EGFR monoclonal antibody (SCT200) as second-line therapy in advanced esophageal squamous cell carcinoma

Safety and efficacy of anti-EGFR monoclonal antibody (SCT200) as second-line therapy in advanced esophageal squamous cell carcinoma

Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with metastatic colorectal cancer

Safety and efficacy of panitumumab in combination with trifluridine/tipiracil for pre-treated patients with unresectable, metastatic colorectal cancer with wild-type RAS: The phase 1/2 APOLLON study

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