| General information |
| Database: | DB00427 |
| Objective: | Preoperative chemoradiation therapy (CRT) has become the standard treatment strategy for patients with resectable esophageal cancer. This multicenterphase 2 study investigated the efficacy of the addition of the epidermal growth factor receptor (EGFR) inhibitor panitumumab to a preoperative CRT regimen with carboplatin, paclitaxel, and radiation therapy in patients with resectable esophageal cancer. |
| Authors: | Kordes S, et al |
| Title: | Preoperative chemoradiation therapy in combination with panitumumab for patients with resectable esophageal cancer: the PACT study. |
| Journal: | Int J Radiat Oncol Biol Phys. |
| Year: | 2014 |
| PMID: | 25195993 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | panitumumab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophageal cancer and esophagusgastroesophageal junction cancer |
| Cancer Subtype: | squamous cell carcinoma or adenocarcinoma of the esophagus or GEJ |
| Therapy Type: | com |
| Therapeutic Combination Type: | 6 |
| Therapeutic Combination Content: | Preoperative chemoradiation therapy + panitumumab |
| Study Type: | multicenterphase II trial, |
| Key Patients Feature: | Patients 18 to 75 years old with histologically proven andpotentially resectable cT13N01 M0 squamous cell carcinoma (SCC) or adenocarcinoma (AC) of the esophagus orGEJ were included. T1N0 tumors were eligible. Stagingwas performed by endoscopic ultrasonography or computedtomography scan. The tumor could extend in the stomachup to 2 cm, and longitudinal and radial tumor size limits didnot exceed 10 and 5 cm, respectively. patients wererequired to demonstrate good clinical condition (WorldHealth Organization [WHO] performance status of 0 to 1;less than 15.0% weight loss); adequate hematologic, renal, and hepatic functions; adequate pulmonary function; andprovide written informed consent |
| Biomarker: | EGFR, HER 2, and P53 |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received preoperative CRT consisting of panitumumab (6 mg/kg) on days 1, 15, and 29, weekly administrations of carboplatin (area under the curve [AUC] = 2), and paclitaxel (50 mg/m(2)) for 5 weeks and concurrent radiation therapy (41.4 Gy in 23 fractions, 5 days per week), followed by surgery. |
| Primary End Point: | pathologic complete response (pCR) rate. |
| Secondary End Point: | NA |
| Patients Number: | 90 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The primary aim was unmet, with a pCR rate of 22%. Patients with AC and squamous cell carcinoma reached a pCR of 14% and 47%, respectively. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NR(not reached) |
| Median OS A vs. C: | NR(not reached) |
| Adverse Event(agent arm): | The main toxicities were hematological, rash, and fatigue. Most toxicities occurred in the first 2 weeks after the last cycle of chemotherapy. The temporary rash caused by panitumumab occurred in a majority of patients (90%). Grade 3 rash occurred in 10 patients (12%). |
| Conclusions: | The addition of panitumumab to CRT with carboplatin and paclitaxel was safe and well tolerated but could not improve pCR rate to the preset criterion of 40%. |