Division of Medical Oncology, Mayo Clinic, Rochester, MN, USA.
Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
Oncologist. 2022 Jul 5;27(7):534-e546. doi: 10.1093/oncolo/oyac002.
This North Central Cancer Treatment Group (NCCTG) N064A (Alliance) phase II trial evaluated upfront chemoradiotherapy incorporating the EGFR inhibitor panitumumab, followed by gemcitabine and panitumumab for unresectable, non-metastatic pancreatic cancer.
The treatment consisted of fluoropyrimidine and panitumumab given concurrently with radiotherapy followed by gemcitabine and panitumumab for 3 cycles followed by maintenance panitumumab. The primary endpoint was the 12-month overall survival (OS) rate and secondary endpoints included confirmed response rate (RR), OS, progression-free survival (PFS), and adverse events. Enrollment of 50 patients was planned and the study fully accrued.
Fifty-two patients were enrolled, but only 51 were treated and included in the analysis. The median age of patients was 65 years and 54.9% were women. Twenty-two patients received at least 1 cycle of systemic therapy following radiotherapy, but 29 patients received chemoradiotherapy only without receiving subsequent chemotherapy after completion of chemoradiotherapy. The overall RR was 5.9% (95% CI: 1.2%-16.2%). The 12-month OS rate was 50% (95% CI: 38%-67%) which fell short of the per-protocol goal for success (51.1%). The median PFS was 7.4 months (95% CI: 4.5-8.6) and the median OS was 12.1 months (95% CI 7.9-15.9). Grade 3 or higher adverse events were reported by 88%.
The combination of panitumumab, chemotherapy, and external beam radiation therapy was associated with very high rates of grades 3-4 toxicities and survival results did not meet the trial's goal for success. This regimen is not recommended for further study (ClinicalTrials.gov Identifier NCT00601627).
这项由美国北中央癌症治疗组（NCCTG）开展的 N064A（Alliance）二期临床试验评估了在不可切除的非转移性胰腺癌患者中采用厄洛替尼联合放化疗的疗效。
患者接受氟嘧啶联合厄洛替尼同步放化疗，随后接受吉西他滨联合厄洛替尼治疗 3 个周期，随后给予厄洛替尼维持治疗。主要终点为 12 个月总生存率（OS），次要终点包括确认缓解率（RR）、OS、无进展生存期（PFS）和不良事件。计划入组 50 例患者，该研究最终完成了全部入组。
共入组 52 例患者，但仅有 51 例接受了治疗并纳入分析。患者中位年龄为 65 岁，54.9%为女性。22 例患者在接受放疗后至少接受了 1 个周期的系统治疗，但 29 例患者在完成放化疗后仅接受了放化疗而未接受后续化疗。总体 RR 为 5.9%（95%CI：1.2%-16.2%）。12 个月 OS 率为 50%（95%CI：38%-67%），未达到方案成功的预设目标（51.1%）。中位 PFS 为 7.4 个月（95%CI：4.5-8.6），中位 OS 为 12.1 个月（95%CI 7.9-15.9）。报告了 88%的 3 级或更高级别的不良事件。
厄洛替尼、化疗和外照射放疗的联合应用导致了非常高的 3-4 级毒性发生率，生存结果未达到试验的成功目标。该方案不推荐进一步研究（ClinicalTrials.gov 标识符：NCT00601627）。
