Benefit of Chemoradiotherapy Versus Chemotherapy After Induction Therapy for Conversion of Unresectable Into Resectable Pancreatic Cancer: The Randomized CONKO-007 Trial.

patients_and_methods

CONKO-007, an investigator-initiated open-label, multicentric, phase III randomized clinical trial, enrolled 525 patients with unresectable tumors, and 495 patients received induction chemotherapy (402 with fluorouracil, irinotecan, and oxaliplatin [FOLFIRINOX] and 93 with gemcitabine).

CONKO-007是一项由研究者发起的开放标签、多中心、III期随机临床试验，招募了525名不可切除肿瘤患者，其中495名患者接受了诱导化疗（402名使用氟尿嘧啶、伊立替康和奥沙利铂[FOLFIRINOX]，93名使用吉西他滨）。

Patients without progression after 3 months of induction chemotherapy (n = 336) were randomly assigned for continuation of the same chemotherapy (n = 167) or CRT (n = 169; 50.4Gy concurrently with gemcitabine).

在诱导化疗3个月后无进展的患者（n = 336）被随机分配继续接受相同的化疗（n = 167）或同步放化疗（n = 169；吉西他滨与50.4Gy同步放疗）。

Resectability was centrally reassessed by a panel of surgeons.

可切除性由一组外科医生中心重新评估。

Surgery was recommended if possible.

如果可能，推荐进行手术。

After an interim analysis, the primary end point was changed from overall survival(OS) to overall R0 resection rate because of slow recruitment.

在中期分析后，由于招募缓慢，主要终点从总生存（OS）更改为总体R0切除率。

The median follow-up was 76 months.

中位随访时间为76个月。

Important planned secondary end points were R0 resection rate in the surgically treated population and OS.

重要的计划次要终点包括手术治疗人群中的R0切除率以及总生存期(OS)。

Results

The primary end point (overall R0 resection rate) was not significantly different between treatment arms with 25% (43 of 169) in the CRT arm versus 18% in the chemotherapy arm (30 of 167; P = .113).

主要终点（总体R0切除率）在治疗组之间没有显著差异，CRT组为25%（169例中有43例），化疗组为18%（167例中有30例；P = .113）。

Secondary end point analysis showed that surgery was performed equally often (P = .91); R0 resection rate in patients who underwent surgery was higher after CRT, 69.4% (43 of 62) compared with chemotherapy alone: 50.0% (30 of 60 patients, P = .04).

次要终点分析显示，手术的频率相等（P = .91）；在进行手术的患者中，CRT后的R0切除率更高，为69.4%（62例中有43例），而仅接受化疗的患者为50.0%（60例中有30例，P = .04）。

Other parameters of resection (ratio of R0/R1/R2/no resection) also favored CRT (P = .02).

其他切除参数（R0/R1/R2/未切除的比例）也倾向于放化疗（P = .02）。

No difference in OS was seen between treatment arms (hazard ratio[HR], 0.937 [95% CI, 0.747 to 1.174]; P = .57; randomly assigned intention-to-treatpatients).

治疗组之间总生存期（OS）无差异（风险比[HR]，0.937 [95% 置信区间，0.747 至 1.174]；P = .57；随机分配的意向治疗患者）

Surgery was associated with longer OS (P < .001, HR, 0.525 [95% CI, 0.408 to 0.676]).

手术与更长的总生存期相关（P < .001，风险比，0.525 [95% 置信区间，0.408 至 0.676]）。

Conclusions

Although not improving overall R0 resection rate or survival, CRT enables a R0 resection in surgically treated patients more often than chemotherapy alone.

尽管并未提高总体R0切除率或生存率，但放化疗（CRT）比单纯化疗更常使接受手术治疗的患者实现R0切除。