Final results of the IFCT-0803 study, a phase II study of cetuximab, pemetrexed, cisplatin, and concurrent radiotherapy in patients with locally advanced, unresectable, stage III, non-squamous, non-small-cell lung cancer
Copyright © 2022 The Authors. Published by Elsevier Masson SAS.. All rights reserved..
PURPOSE: Roughly 20% of patients with non-small-cell lung cancer exhibit locally advanced, unresectable, stage III disease. Concurrent platinum-based chemoradiotherapy is the backbone treatment, which is followed by maintenance immunotherapy, yet with poor long-term prognosis. This phase II trial (IFCT-0803) sought to evaluate whether adding cetuximab to cisplatin and pemetrexed chemoradiotherapy would improve its efficacy in these patients.
MATERIALS AND METHODS: Eligible patients received weekly cetuximab (loading dose 400mg/m2 day 1; subsequent weekly 250mg/m2 doses until two weeks postradiotherapy). Chemotherapy comprised cisplatin (75mg/m2) and pemetrexed (500mg/m2), both delivered on day 1 of a 21-day cycle of maximally four. Irradiation with maximally 66Gy started on day 22. Disease control rate at week 16 was the primary endpoint.
RESULTS: One hundred and six patients were included (99 eligible patients). Compliance exceeded 95% for day 1 of chemotherapy cycles 1 to 4, with 76% patients receiving the 12 planned cetuximab doses. Maximal grade 3 toxicity occurred in 63% patients, and maximal grade 4 in 9.6%. The primary endpoint involving the first 95 eligible patients comprised two (2.1%) complete responses, 57 (60.0%) partial responses, and 27 (28.4%) stable diseases. This 90.5% disease control rate (95% confidence interval [95% CI]: 84.6%-96.4%) was achieved at week 16. After median 63.0-month follow-up, one-year and two-year survival rates were 75.8% and 59.5%. Median overall survival was 35.8months (95% CI: 23.5-NR), and median progression-free survival 14.4months (95% CI: 11.2-18.8), with one-year and two-year progression-free survival rates of 57.6% and 34.3%.
CONCLUSION: These survival rates compare favourably with published data, thus justifying further development of cetuximab-based induction chemoradiotherapy.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2022 |
|---|---|
| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:26 |
|---|---|
| Enthalten in: |
Cancer radiotherapie : journal de la Societe francaise de radiotherapie oncologique - 26(2022), 5 vom: 30. Sept., Seite 670-677 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Trédaniel, J [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 16.08.2022 Date Revised 16.08.2022 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.canrad.2021.12.005 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM337912653 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM337912653 | ||
| 003 | DE-627 | ||
| 005 | 20231225235507.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2022 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.canrad.2021.12.005 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1126.xml |
| 035 | |a (DE-627)NLM337912653 | ||
| 035 | |a (NLM)35260342 | ||
| 035 | |a (PII)S1278-3218(22)00035-X | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Trédaniel, J |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Final results of the IFCT-0803 study, a phase II study of cetuximab, pemetrexed, cisplatin, and concurrent radiotherapy in patients with locally advanced, unresectable, stage III, non-squamous, non-small-cell lung cancer |
| 264 | 1 | |c 2022 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 16.08.2022 | ||
| 500 | |a Date Revised 16.08.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022 The Authors. Published by Elsevier Masson SAS.. All rights reserved. | ||
| 520 | |a PURPOSE: Roughly 20% of patients with non-small-cell lung cancer exhibit locally advanced, unresectable, stage III disease. Concurrent platinum-based chemoradiotherapy is the backbone treatment, which is followed by maintenance immunotherapy, yet with poor long-term prognosis. This phase II trial (IFCT-0803) sought to evaluate whether adding cetuximab to cisplatin and pemetrexed chemoradiotherapy would improve its efficacy in these patients | ||
| 520 | |a MATERIALS AND METHODS: Eligible patients received weekly cetuximab (loading dose 400mg/m2 day 1; subsequent weekly 250mg/m2 doses until two weeks postradiotherapy). Chemotherapy comprised cisplatin (75mg/m2) and pemetrexed (500mg/m2), both delivered on day 1 of a 21-day cycle of maximally four. Irradiation with maximally 66Gy started on day 22. Disease control rate at week 16 was the primary endpoint | ||
| 520 | |a RESULTS: One hundred and six patients were included (99 eligible patients). Compliance exceeded 95% for day 1 of chemotherapy cycles 1 to 4, with 76% patients receiving the 12 planned cetuximab doses. Maximal grade 3 toxicity occurred in 63% patients, and maximal grade 4 in 9.6%. The primary endpoint involving the first 95 eligible patients comprised two (2.1%) complete responses, 57 (60.0%) partial responses, and 27 (28.4%) stable diseases. This 90.5% disease control rate (95% confidence interval [95% CI]: 84.6%-96.4%) was achieved at week 16. After median 63.0-month follow-up, one-year and two-year survival rates were 75.8% and 59.5%. Median overall survival was 35.8months (95% CI: 23.5-NR), and median progression-free survival 14.4months (95% CI: 11.2-18.8), with one-year and two-year progression-free survival rates of 57.6% and 34.3% | ||
| 520 | |a CONCLUSION: These survival rates compare favourably with published data, thus justifying further development of cetuximab-based induction chemoradiotherapy | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a CPNPC de stade III | |
| 650 | 4 | |a Cetuximab | |
| 650 | 4 | |a Chimioradiothérapie concomitante | |
| 650 | 4 | |a Cisplatin | |
| 650 | 4 | |a Cisplatine | |
| 650 | 4 | |a Concurrent chemoradiotherapy | |
| 650 | 4 | |a Cétuximab | |
| 650 | 4 | |a Pemetrexed | |
| 650 | 4 | |a Pémétrexed | |
| 650 | 4 | |a Stage III NSCLC | |
| 650 | 7 | |a Pemetrexed |2 NLM | |
| 650 | 7 | |a 04Q9AIZ7NO |2 NLM | |
| 650 | 7 | |a Cetuximab |2 NLM | |
| 650 | 7 | |a PQX0D8J21J |2 NLM | |
| 650 | 7 | |a Cisplatin |2 NLM | |
| 650 | 7 | |a Q20Q21Q62J |2 NLM | |
| 700 | 1 | |a Barlési, F |e verfasserin |4 aut | |
| 700 | 1 | |a Le Péchoux, C |e verfasserin |4 aut | |
| 700 | 1 | |a Lerouge, D |e verfasserin |4 aut | |
| 700 | 1 | |a Pichon, É |e verfasserin |4 aut | |
| 700 | 1 | |a Le Moulec, S |e verfasserin |4 aut | |
| 700 | 1 | |a Moreau, L |e verfasserin |4 aut | |
| 700 | 1 | |a Friard, S |e verfasserin |4 aut | |
| 700 | 1 | |a Westeel, V |e verfasserin |4 aut | |
| 700 | 1 | |a Petit, L |e verfasserin |4 aut | |
| 700 | 1 | |a Carré, O |e verfasserin |4 aut | |
| 700 | 1 | |a Guichard, F |e verfasserin |4 aut | |
| 700 | 1 | |a Raffy, O |e verfasserin |4 aut | |
| 700 | 1 | |a Villa, J |e verfasserin |4 aut | |
| 700 | 1 | |a Prévost, A |e verfasserin |4 aut | |
| 700 | 1 | |a Langlais, A |e verfasserin |4 aut | |
| 700 | 1 | |a Morin, F |e verfasserin |4 aut | |
| 700 | 1 | |a Wislez, M |e verfasserin |4 aut | |
| 700 | 1 | |a Giraud, P |e verfasserin |4 aut | |
| 700 | 1 | |a Zalcman, G |e verfasserin |4 aut | |
| 700 | 1 | |a Mornex, F |e verfasserin |4 aut | |
| 700 | 0 | |a French Cooperative Thoracic Intergroup (IFCT) |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Cancer radiotherapie : journal de la Societe francaise de radiotherapie oncologique |d 1998 |g 26(2022), 5 vom: 30. Sept., Seite 670-677 |w (DE-627)NLM092193420 |x 1769-6658 |7 nnns |
| 773 | 1 | 8 | |g volume:26 |g year:2022 |g number:5 |g day:30 |g month:09 |g pages:670-677 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.canrad.2021.12.005 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 26 |j 2022 |e 5 |b 30 |c 09 |h 670-677 | ||