Phase III trial comparing 3–6 months of adjuvant FOLFOX4/XELOX in stage II–III colon cancer: safety and compliance in the TOSCA trial

Rimassa, Lorenza; Bilancia, Domenico; Rosati, Gerardo; Montesarchio, Vincenzo; Iaffaioli, Rosario Vincenzo; Nasti, Guglielmo; Daniele, Bruno; Zagonel, Vittorina; Lonardi, Sara; Pella, Nicoletta; Aprile, Giuseppe; Pasini, Felice; Marchetti, Paolo; Romiti, Adriana; Ciuffreda, Libero; Ferrari, Daris; Foa, Paolo; Zaniboni, Alberto; Labianca, Roberto; Mosconi, S.; Sobrero, Alberto; Bidoli, Paolo; Cazzaniga, Massimiliano; Beretta, Giordano Domenico; Corsi, D.C.; Cortesi, Enrico; Barni, Sandro; Petrelli, Fausto; Cantore, Maurizio; Maiello, Evaristo; Cinieri, Saverio; Banzi, M.; Santoro, Armando; Artioli, Fabrizio; Mattioli, Rodolfo; Amoroso, Domenico; Amadori, Dino; Frassineti, L.; Turci, D.; Ravaioli, Alberto; Bajetta, Emilio; Bartolomeo, Maria Di; Giannì, L.; Ronzoni, Monica; Ionta, Maria Teresa; Massidda, B.; Scartozzi, Mario; Zampino, Maria Giulia; Bochicchio, Anna; Ciarlo, A.; Leo, A. Di; Placido, Sabino De; Carlomagno, Cristiano; Adamo, Vincenzo; Natale, D.; Rulli, Eliana; Galli, Francesca; Poli, D.; Torri, V.

doi:10.1093/annonc/mdw404

Cited by 51 publications

(49 citation statements)

References 11 publications

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“…Previous studies reported that 32.6%-42% of patients had grade 3-4 neutropenia after 6 months of postoperative adjuvant chemotherapy (FOLFOX/CapeOX [capecitabine + L-leucovorin + oxaliplatin]) (19)(20)(21). Additionally, the TOSCA trial investigated the optimal therapy period (3 vs. 6 months) and reported that the rate of grade 3-4 neutropenia in the 3-month arm was 19.3% (22). Based on these results, our results are considered reasonable.…”

Section: Discussionmentioning

confidence: 99%

Feasibility of Neoadjuvant FOLFOX Therapy Without Radiotherapy for Baseline Resectable Rectal Cancer

Koizumi

Yamada

Shinji

et al. 2018

In Vivo

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Section: Discussionmentioning

confidence: 99%

Feasibility of Neoadjuvant FOLFOX Therapy Without Radiotherapy for Baseline Resectable Rectal Cancer

Koizumi

Yamada

Shinji

et al. 2018

In Vivo

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“…Although they have not provided survival data yet, the results were in the same context as the findings of this study. We are expecting valuable long-term results from this multicenter prospective randomized trial [16]. …”

Section: Discussionmentioning

confidence: 99%

Effect of a Shortened Duration of FOLFOX Chemotherapy on the Survival Rate of Patients with Stage II and III Colon Cancer

Ji¹,

Hong²,

Kim³

et al. 2017

Chemotherapy

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Background: FOLFOX chemotherapy is widely used as an adjuvant treatment for advanced colon cancer. The duration of adjuvant chemotherapy is usually set to 6 months, which is based on a former study of 5-fluorouracil/leucovorin chemotherapy. However, the FOLFOX regimen is known to have complications, such as peripheral neuropathy. The aim of this study was to compare the survival rates and complications experienced by patients receiving either 4 or 6 months of FOLFOX chemotherapy. Methods: Retrospective data analysis was performed for stage II and III patients who underwent radical resection of colon cancer. We compared the 5-year survival rates and the occurrence of complications in patients who completed only 8 cycles of FOLFOX chemotherapy with patients who completed 12 cycles of chemotherapy. Results: Among 188 patients who underwent adjuvant FOLFOX chemotherapy for stage II or III colon cancer, 83 (44.1%) completed 6 months of FOLFOX chemotherapy and 64 (34.0%) patients discontinued after 4 months of chemotherapy. The 5-year overall survival and disease-free survival rates did not show a significant difference. Patients in the 6-month group had peripheral neuropathy more frequently (p = 0.028). Conclusions: Five-year overall and disease-free survival were not significantly different between the 2 groups. Large-scale prospective studies are necessary for the analysis of complications and survival rates.

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“…In light of recent research the indication for adjuvant chemotherapy is considered for patients thought to have associated high risk factors even if they do not present positive nodes or metastases at the time of the initial diagnosis (7)(8)(9)(10)(11)(12).…”

Section: Introductionmentioning

confidence: 99%

Prognostic Factors Analysis for Colon Cancer with Lymph Node Negative

Vilcea¹,

Romain²,

Rohr³

et al. 2018

chr

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We performed a retrospective analysis regarding the impact of prognosis factors for patients with high recurrence risk in stages I and II. We studied 99 patients with T2, T3 and T4 tumors who suffered a curative resection and whom may or may not present indication for adjuvant chemotherapy according to histoprognostic factors and molecular biomarkers. We performed a univariate Cox regression which highlighted that male sex is a risk factor for disease relapse (HR=5.53, p 0.05, IC95% = 1.29 to 23.73). Although with a low statistical significance effect, T4 tumors seems to be associated with a poor prognosis regarding disease relapse (HR = 2.56, p = 0.06, IC95% = 0.94 to 6.99) compared to T2 and T3 tumors. Patients with d'MMR (MSI-H) seem to have a more favorable evolution compared to patients with p'MMR (MSS/MSI-L) - HR (d'MMR vs p'MMR) = 0.19, IC95% = 0.02 to 1.61, p = 0.13. We believe that it would be useful for MSS / MSI to be systematically analyzed, our data suggesting a better response of d`MMR patients to adjuvant chemotherapy. The multivariate Cox regression did not identify independent risk factors of relapse.

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Phase III trial comparing 3–6 months of adjuvant FOLFOX4/XELOX in stage II–III colon cancer: safety and compliance in the TOSCA trial

Cited by 51 publications

References 11 publications

Feasibility of Neoadjuvant FOLFOX Therapy Without Radiotherapy for Baseline Resectable Rectal Cancer

Feasibility of Neoadjuvant FOLFOX Therapy Without Radiotherapy for Baseline Resectable Rectal Cancer

Effect of a Shortened Duration of FOLFOX Chemotherapy on the Survival Rate of Patients with Stage II and III Colon Cancer

Prognostic Factors Analysis for Colon Cancer with Lymph Node Negative

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