|Kelsen, DP et al|
|Abramson Cancer Center of the University of Pennsylvania|
| Last Modified: November 1, 2001
Reviewers: Kenneth Blank, MD
Materials and Methods
Patients were randomly assigned to either surgery alone or three cycles of chemotherapy (cisplatin and 5FU) followed by surgery and two more cycles of chemotherapy post-operatively. Patients underwent the same surgical procedure in both groups. Four hundred forty patients were enrolled; slightly over half of them had adenocarcinoma. Acceptable procedures included the procedures listed below:
The overall response rate to chemotherapy was 19%. The chemotherapy was reasonably well tolerated. There were similar rates of surgical morbidity and mortality on both study arms. The median survival time for both groups was similar. Those receiving surgery alone had a median survival of 16 months compared to 15 months for patients receiving chemotherapy. The percent of patients surviving at two years was also similar: 35% for the chemotherapy group and 37% for the surgery alone group. Chemotherapy did not alter the rates of local or distant recurrence.
The addition of chemotherapy did not improve the survival rate over surgery alone in patients with cancer of the esophagus. This result disappointed many in the cancer field because chemotherapy had previously been shown to be effective concurrent and following radiotherapy. In addition, other trials have found chemotherapy to be effective with surgery. The authors speculate the ineffectiveness of chemotherapy in this trial may be due to inadequate dose intensity of chemotherapy, noting that only two-thirds of the patients received all the planned cycles.