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Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer: results of the first prospective randomized phase II trial.

Golcher H, Brunner TB, Witzigmann H, Marti L, Bechstein WO, Bruns C, Jungnickel H, Schreiber S, Grabenbauer GG, Meyer T, Merkel S, Fietkau R, Hohenberger W - Strahlenther Onkol (2014)

Bottom Line: B; intention-to-treat analysis; P = 0.96).After tumor resection, mOS was 18.9 vs. 25.0 months (A vs.B; P = 0.79).

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, University Hospital Erlangen, Krankenhausstr. 12, 91054, Erlangen, Germany, henriette.golcher@uk-erlangen.de.

ABSTRACT

Background: In nonrandomized trials, neoadjuvant treatment was reported to prolong survival in patients with pancreatic cancer. As neoadjuvant chemoradiation is established for the treatment of rectal cancer we examined the value of neoadjuvant chemoradiotherapy in pancreatic cancer in a randomized phase II trial. Radiological staging defining resectability was basic information prior to randomization in contrast to adjuvant therapy trials resting on pathological staging.

Patients and methods: Patients with resectable adenocarcinoma of the pancreatic head were randomized to primary surgery (Arm A) or neoadjuvant chemoradiotherapy followed by surgery (Arm B), which was followed by adjuvant chemotherapy in both arms. A total of 254 patients were required to detect a 4.33-month improvement in median overall survival (mOS).

Results: The trial was stopped after 73 patients; 66 patients were eligible for analysis. Twenty nine of 33 allocated patients received chemoradiotherapy. Radiotherapy was completed in all patients. Chemotherapy was changed in 3 patients due to toxicity. Tumor resection was performed in 23 vs. 19 patients (A vs. B). The R0 resection rate was 48% (A) and 52% (B, P = 0.81) and (y)pN0 was 30% (A) vs. 39% (B, P = 0.44), respectively. Postoperative complications were comparable in both groups. mOS was 14.4 vs. 17.4 months (A vs. B; intention-to-treat analysis; P = 0.96). After tumor resection, mOS was 18.9 vs. 25.0 months (A vs. B; P = 0.79).

Conclusion: This worldwide first randomized trial for neoadjuvant chemoradiotherapy in pancreatic cancer showed that neoadjuvant chemoradiation is safe with respect to toxicity, perioperative morbidity, and mortality. Nevertheless, the trial was terminated early due to slow recruiting and the results were not significant. ISRCTN78805636; NCT00335543.

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Kaplan–Meier curves (intention to treat analysis) for a overall survival, b time to progression, c overall survival after R0 resection, and d overall survival according to (y)pN status. CRT chemoradiation; O events [a, c, and d deaths or b progression of disease] observed; N overall number; pNx no tumor resection (d)
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Fig2: Kaplan–Meier curves (intention to treat analysis) for a overall survival, b time to progression, c overall survival after R0 resection, and d overall survival according to (y)pN status. CRT chemoradiation; O events [a, c, and d deaths or b progression of disease] observed; N overall number; pNx no tumor resection (d)

Mentions: The median follow-up for all living patients was 61 months (range 37–79 months). There were 29 deaths in Arm A and 31 deaths in Arm B. At intention-to-treat analysis mOS between the two arms was not significantly different for all patients irrespective of resection status (Arm A, 14.4 months; Arm B 17.4 months; P = 0.96; Fig. 2a).


Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer: results of the first prospective randomized phase II trial.

Golcher H, Brunner TB, Witzigmann H, Marti L, Bechstein WO, Bruns C, Jungnickel H, Schreiber S, Grabenbauer GG, Meyer T, Merkel S, Fietkau R, Hohenberger W - Strahlenther Onkol (2014)

Kaplan–Meier curves (intention to treat analysis) for a overall survival, b time to progression, c overall survival after R0 resection, and d overall survival according to (y)pN status. CRT chemoradiation; O events [a, c, and d deaths or b progression of disease] observed; N overall number; pNx no tumor resection (d)
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4289008&req=5

Fig2: Kaplan–Meier curves (intention to treat analysis) for a overall survival, b time to progression, c overall survival after R0 resection, and d overall survival according to (y)pN status. CRT chemoradiation; O events [a, c, and d deaths or b progression of disease] observed; N overall number; pNx no tumor resection (d)
Mentions: The median follow-up for all living patients was 61 months (range 37–79 months). There were 29 deaths in Arm A and 31 deaths in Arm B. At intention-to-treat analysis mOS between the two arms was not significantly different for all patients irrespective of resection status (Arm A, 14.4 months; Arm B 17.4 months; P = 0.96; Fig. 2a).

Bottom Line: B; intention-to-treat analysis; P = 0.96).After tumor resection, mOS was 18.9 vs. 25.0 months (A vs.B; P = 0.79).

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, University Hospital Erlangen, Krankenhausstr. 12, 91054, Erlangen, Germany, henriette.golcher@uk-erlangen.de.

ABSTRACT

Background: In nonrandomized trials, neoadjuvant treatment was reported to prolong survival in patients with pancreatic cancer. As neoadjuvant chemoradiation is established for the treatment of rectal cancer we examined the value of neoadjuvant chemoradiotherapy in pancreatic cancer in a randomized phase II trial. Radiological staging defining resectability was basic information prior to randomization in contrast to adjuvant therapy trials resting on pathological staging.

Patients and methods: Patients with resectable adenocarcinoma of the pancreatic head were randomized to primary surgery (Arm A) or neoadjuvant chemoradiotherapy followed by surgery (Arm B), which was followed by adjuvant chemotherapy in both arms. A total of 254 patients were required to detect a 4.33-month improvement in median overall survival (mOS).

Results: The trial was stopped after 73 patients; 66 patients were eligible for analysis. Twenty nine of 33 allocated patients received chemoradiotherapy. Radiotherapy was completed in all patients. Chemotherapy was changed in 3 patients due to toxicity. Tumor resection was performed in 23 vs. 19 patients (A vs. B). The R0 resection rate was 48% (A) and 52% (B, P = 0.81) and (y)pN0 was 30% (A) vs. 39% (B, P = 0.44), respectively. Postoperative complications were comparable in both groups. mOS was 14.4 vs. 17.4 months (A vs. B; intention-to-treat analysis; P = 0.96). After tumor resection, mOS was 18.9 vs. 25.0 months (A vs. B; P = 0.79).

Conclusion: This worldwide first randomized trial for neoadjuvant chemoradiotherapy in pancreatic cancer showed that neoadjuvant chemoradiation is safe with respect to toxicity, perioperative morbidity, and mortality. Nevertheless, the trial was terminated early due to slow recruiting and the results were not significant. ISRCTN78805636; NCT00335543.

Show MeSH
Related in: MedlinePlus