The addition of panitumumab to neoadjuvant CRT in patients with KRAS wild-type LARC resulted in a high pNC/CR rate, mostly grade 3 DC. The results of both treatment arms exceeded prespecified thresholds. The addition of panitumumab increased toxicity.
Background: To report acute and late toxicity in prostate cancer patients treated by dose escalated intensity-modulated radiation therapy (IMRT) and organ tracking.
Caudad position shifts up to 36 mm were observed. Gold markers represent a valuable tool to ensure setup accuracy and precise dose delivery in fractionated HDR-B monotherapy of prostate cancer.
With great interest we read the article by Brown et al, who reported the results of a phase 2 study using gemcitabine and cisplatin in patients with advanced endometrial cancer. 1 Although we recognize the reported impressive activity of this regimen, we believe there are several aspects that should lead to a cautious interpretation of the data. First, the study by Brown et al was a rather small phase 2 study, with dose modifications performed during an ongoing trial. Moreover, despite modification of the protocol, 80% of the evaluable patients still required dose reductions and grade 3/4 hematotoxicity was observed in nearly 50% of the treated women. In total, 18 of 20 patients experienced grade 3/4 toxic effects.Although the authors viewed the high toxicity rates in the context of the pretreatment of these patients, we do not agree that this is a satisfying argument in the palliative setting. For one, the combination of weekly carboplatin and paclitaxel has also shown remarkable activity but less toxicity. 2 Of course, a combined regimen of gemcitabine and cisplatin may have particular advantages, as stated by the authors. 1 Nevertheless, in our view this regimen does not appear to be appropriate for palliative treatment due to the reported toxicity. Accepting the high antitumoral activity found in these 20 patients, further trials should evaluate a better tolerated schedule (eg, a biweekly application of gemcitabine and cisplatin, potentially combined with a biological agent).
762 Background: We conducted a randomized phase II multicenter trial evaluate the anti-epidermal growth factor receptor (EGFR) panitumumab (P) in combination with CRT with standard-dose capecitabine as neoadjuvant treatment for wild-type KRAS LARC. Methods: Patients with wild-type KRAS, T3-4 and/or N+ LARC were randomly assigned to receive CRT either with or without P (6 mg/kg). The primary end-point was pathological near-complete or complete tumor response (pNC/CR), defined as grade 3 (pNCR) or 4 (pCR) histological regression by Dworak classification (DC). Secondary end-points were pathological response, R0-resection, sphincter preservation, downstaging, time to local relapse, time to distant failure and disease-free survival (DFS). Results: Patients with wild-type KRAS, T3-4 and/or N+ LARC were randomly assigned to receive CRT either with or without P (6 mg/kg). The primary end-point was pathological near-complete or complete tumor response (pNC/CR), defined as grade 3 (pNCR) or 4 (pCR) histological regression by Dworak classification (DC). Secondary end-points were pathological response, R0-resection, sphincter preservation, downstaging, time to local relapse, time to distant failure and disease-free survival (DFS). Conclusions: An addition of panitumumab to neoadjuvant CRT in patients with KRAS wild-type LARC resulted in a high pNC/CR rate, mostly grade 3 DC. Up to date no local recurrence occurred and DFS compared favorably to other trials. Clinical trial information: NCT00814619.
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