OC-0250: First results of the PETACC-6 randomized phase III trial in locally advanced rectal cancer

Haustermans, Karin; Schmoll, H.-J.; Price, Timothy; Nordlinger, Bernard; Hofheinz, R. D.; Daisne, Jean-François; Janssens, J; Schmidt, P.; Reinel, H.; Cutsem, Éric Van

doi:10.1016/s0167-8140(15)30355-8

Cited by 9 publications

(14 citation statements)

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“…The remaining 2 articles were removed because data were not available. The meta-analysis included 7 trials, with a total of 5415 patients: STAR-01 trial [17], ACCORD12/0405 trial [18, 25], NSABP R-04 trial [16, 19], CAO/ARO/AIO-04 trial [4, 20], JIAO 2015 [21], FOWARC study [22] and PETACC-6 trial [26, 27]. Figure 1 shows the literature screening process, and Table 1 reveals the characteristics of the included studies.…”

Section: Resultsmentioning

confidence: 99%

“…All trials described the reasons of incomplete outcome data. Two abstracts did not report long-term follow-up outcomes according to their protocol currently; thus, a selective report bias may be present [22, 26]. Figure 2 presents the quality of all evaluated trials that were included.…”

Section: Resultsmentioning

confidence: 99%

“…A larger sample size is likely needed to obtain significant differences [29, 30]. Negative DFS results were obtained from ACCORD-12 [18, 25], JIAO 2015 [21] and PETACC-6 [26], whereas a positive result was obtained from CAO/ARO/AIO-04 [20, 25]. CAO/ARO/AIO-04 revealed that oxaliplatin groups showed a significant DFS benefit (RR=0.82, 95% CI: 0.68–0.97, P < 0.05).…”

Section: Discussionmentioning

confidence: 99%

“…Some researchers believed that the reason for the DFS benefit was that CAO/ARO/AIO-04 adopted oxaliplatin-based postoperative adjuvant chemotherapy regimens [20, 25, 30]. PETACC-6, which also applied to oxaliplatin in postoperative adjuvant chemotherapy, did not achieve a similar conclusion [26, 30]. In addition to the above reason, an increased intensity and good compliance in the adjuvant chemotherapy regimens was noted for the treatment groups compared with the control group in CAO/ARO/AIO-04, which may explain the difference [20, 30].…”

Section: Discussionmentioning

confidence: 99%

“…To date, seven phase III randomized controlled trials investigated the effect of OX in FU/capecitabine-based neoadjuvant therapy for LARC: STAR-01 in Italy [17], ACCORD12/0405 in France [18, 25], NSABP R-04 in the USA [16, 19], CAO/ARO/AIO-04 in Germany [4, 20], JIAO 2015 [21] and FOWARC study [22] in China, and PETACC-6 (NCT00766155) in Europe [26, 27]. However, these studies did not reach a consistent conclusion, especially regarding whether the addition of oxaliplatin improves disease-free survival (DFS).…”

Section: Introductionmentioning

confidence: 99%

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Fluorouracil-based neoadjuvant chemoradiotherapy with or without oxaliplatin for treatment of locally advanced rectal cancer: An updated systematic review and meta-analysis

Yang

Cao

et al. 2016

Oncotarget

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To measure the safety and efficacy of oxaliplatin (OX) application in neoadjuvant chemoradiotherapy (CRT) for locally advanced rectal cancer (LARC), EMBASE, PubMed, Cochrane Library, and Web of Science were used for a literature search. Cochrane's risk of bias tool of randomized controlled trials (RCTs) was used for quality evaluation. The statistical analyses were performed using RevMan 5.3. In addition, 95% confidence intervals (CIs) and pooled risk ratios (RRs) were calculated. Seven RCTs were included in our meta-analysis. After adding OX to fluoropyrimidine (FU), a marginal significant improvement in disease-free survival was noted compared with FU alone (RR = 0.89, 95% CI: 0.78–1.00; P = 0.05). Neoadjuvant CRT with OX significantly decreased the distant metastasis rate (RR = 0.79, 95% CI: 0.67–0.94, P = 0.007). However, no improvement in the local recurrence rate (RR = 0.86, 95% CI: 0.68–1.08; P = 0.19) was noted. In addition, neoadjuvant CRT with OX also significantly increased the pathologic complete response (RR = 1.24, 95% CI: 1.02–1.51; P = 0.03). Grade 3–4 acute toxicity and grade 3–4 diarrhea was considerably higher for OX/FU compared with FU alone. In conclusion, the use of OX on the basis of FU/capecitabine in preoperative CRT is feasible. LARC patients are likely to benefit from CRT regimens with OX.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Fluorouracil-based neoadjuvant chemoradiotherapy with or without oxaliplatin for treatment of locally advanced rectal cancer: An updated systematic review and meta-analysis

Yang

Cao

et al. 2016

Oncotarget

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Association of Treatment Adherence With Oncologic Outcomes for Patients With Rectal Cancer

et al. 2020

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Recent advances of neoadjuvant chemoradiotherapy in rectal cancer: Future treatment perspectives

Yamashita

Matsuda

Hasegawa

et al. 2018

Annals of Gastroent Surgery

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Neoadjuvant chemoradiotherapy (nCRT) has been widely used as a multidisciplinary approach for stage II/III rectal cancer. However, its safety and efficacy are controversial because previous studies have shown conflicting outcomes. The present review aimed to elucidate the benefits and limitations of nCRT for patients with rectal cancer. Future perspectives of nCRT are also described. No recent randomized trials have been able to show a survival benefit, although many studies have demonstrated good local control with the use of fluoropyrimidine (e.g. 5‐fluorouracil [FU] or capecitabine)‐based nCRT. Addition of oxaliplatin (OX) to FU‐based nCRT might improve overall survival by preventing distant metastasis, as shown in recent meta‐analyses. However, control of adverse effects is an important concern with this treatment. New treatment strategies such as nonoperative management (watch and wait policy) and total neoadjuvant therapy (TNT) are promising, but the establishment of reliable diagnostic methods of metastasis is essential. Development of new biomarkers is also necessary to select patients who are more likely to benefit from nCRT.

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OC-0250: First results of the PETACC-6 randomized phase III trial in locally advanced rectal cancer

Cited by 9 publications

References 0 publications

Fluorouracil-based neoadjuvant chemoradiotherapy with or without oxaliplatin for treatment of locally advanced rectal cancer: An updated systematic review and meta-analysis

Fluorouracil-based neoadjuvant chemoradiotherapy with or without oxaliplatin for treatment of locally advanced rectal cancer: An updated systematic review and meta-analysis

Association of Treatment Adherence With Oncologic Outcomes for Patients With Rectal Cancer

Recent advances of neoadjuvant chemoradiotherapy in rectal cancer: Future treatment perspectives

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