Lunchbox trial: A randomized phase III trial of cisplatin and irradiation followed by carboplatin and paclitaxel versus sandwich therapy of carboplatin and paclitaxel followed by irradiation then carboplatin and paclitaxel for advanced endometrial carcinoma
The objective was to compare sequencing strategies for treatment of advanced endometrial carcinoma. Patients were eligible if they had FIGO 2009 Stage III or IVA endometrial carcinoma or Stage I or II serous or clear cell endometrial carcinoma and positive cytology. Patients were randomized to: Cisp...
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| Veröffentlicht in: | Gynecologic oncology 2024-01, Vol.180, p.63-69 |
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| creator | Barlin, Joyce N. Mahar, Barb Ata, Ashar Cormier, Beatrice Michelin, David Salani, Ritu Backes, Floor Levinson, Kimberly Cantrell, Leigh Anne Weinberg, Lori Wagreich, Allison Savage, Duncan Gasson, Christian Denniston, Kyle Martin, Jovana McElrath, Timothy Timmins, Patrick F. |
| description | The objective was to compare sequencing strategies for treatment of advanced endometrial carcinoma.
Patients were eligible if they had FIGO 2009 Stage III or IVA endometrial carcinoma or Stage I or II serous or clear cell endometrial carcinoma and positive cytology. Patients were randomized to: Cisplatin 50 mg/m2 IV Days 1 and 29 plus radiation followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 4 cycles (chemoRT then chemo) vs. Carboplatin AUC 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles followed by radiation followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles (sandwich therapy). Futility analysis was planned. The primary objective was to determine if chemoRT then chemo improves recurrence-free survival (RFS) compared to sandwich therapy.
Of the 48 patients enrolled at 8 sites, 42 patients were eligible for futility analysis, and the trial was closed early. The median follow-up was 30.9 months. The 3-year RFS was 85.7% (95% confidence interval [CI], 62 to 95) in the chemoRT then chemo arm and 73.4% (95% CI, 43 to 89) in the sandwich therapy group (p = 0.58). The 3-year overall survival (OS) was 88.4% (95% CI, 61 to 97) in the chemoRT then chemo arm and 80.9% (95% CI, 51 to 93) in the sandwich therapy group (p = 0.55).
There was no observed significant difference between chemoRT then chemo compared to sandwich therapy in terms of RFS, OS, or adverse events, although the trial was underpowered and closed early due to low accrual.
•Randomized prospective trial results on chemotherapy and radiation sequencing in advanced endometrial cancer.•No observed difference in survival between chemoradiation followed by chemo and sandwich therapy in endometrial cancer.•Similar tolerability and location of recurrence using various sequencing strategies in advanced endometrial cancer. |
| doi_str_mv | 10.1016/j.ygyno.2023.11.012 |
| format | Article |
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Patients were eligible if they had FIGO 2009 Stage III or IVA endometrial carcinoma or Stage I or II serous or clear cell endometrial carcinoma and positive cytology. Patients were randomized to: Cisplatin 50 mg/m2 IV Days 1 and 29 plus radiation followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 4 cycles (chemoRT then chemo) vs. Carboplatin AUC 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles followed by radiation followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles (sandwich therapy). Futility analysis was planned. The primary objective was to determine if chemoRT then chemo improves recurrence-free survival (RFS) compared to sandwich therapy.
Of the 48 patients enrolled at 8 sites, 42 patients were eligible for futility analysis, and the trial was closed early. The median follow-up was 30.9 months. The 3-year RFS was 85.7% (95% confidence interval [CI], 62 to 95) in the chemoRT then chemo arm and 73.4% (95% CI, 43 to 89) in the sandwich therapy group (p = 0.58). The 3-year overall survival (OS) was 88.4% (95% CI, 61 to 97) in the chemoRT then chemo arm and 80.9% (95% CI, 51 to 93) in the sandwich therapy group (p = 0.55).
There was no observed significant difference between chemoRT then chemo compared to sandwich therapy in terms of RFS, OS, or adverse events, although the trial was underpowered and closed early due to low accrual.
•Randomized prospective trial results on chemotherapy and radiation sequencing in advanced endometrial cancer.•No observed difference in survival between chemoradiation followed by chemo and sandwich therapy in endometrial cancer.•Similar tolerability and location of recurrence using various sequencing strategies in advanced endometrial cancer.</description><identifier>ISSN: 0090-8258</identifier><identifier>ISSN: 1095-6859</identifier><identifier>EISSN: 1095-6859</identifier><identifier>DOI: 10.1016/j.ygyno.2023.11.012</identifier><identifier>PMID: 38052110</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Carboplatin ; Chemoradiation ; Cisplatin ; Endometrial cancer ; Endometrial Neoplasms - drug therapy ; Endometrial Neoplasms - radiotherapy ; Female ; Humans ; Paclitaxel ; Sandwich therapy</subject><ispartof>Gynecologic oncology, 2024-01, Vol.180, p.63-69</ispartof><rights>2023 Elsevier Inc.</rights><rights>Copyright © 2023 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c404t-af00a6e5aafb2b72faf537d1cca452cc6e47ba05778035274276f7f4ef3881a63</citedby><cites>FETCH-LOGICAL-c404t-af00a6e5aafb2b72faf537d1cca452cc6e47ba05778035274276f7f4ef3881a63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ygyno.2023.11.012$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38052110$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Barlin, Joyce N.</creatorcontrib><creatorcontrib>Mahar, Barb</creatorcontrib><creatorcontrib>Ata, Ashar</creatorcontrib><creatorcontrib>Cormier, Beatrice</creatorcontrib><creatorcontrib>Michelin, David</creatorcontrib><creatorcontrib>Salani, Ritu</creatorcontrib><creatorcontrib>Backes, Floor</creatorcontrib><creatorcontrib>Levinson, Kimberly</creatorcontrib><creatorcontrib>Cantrell, Leigh Anne</creatorcontrib><creatorcontrib>Weinberg, Lori</creatorcontrib><creatorcontrib>Wagreich, Allison</creatorcontrib><creatorcontrib>Savage, Duncan</creatorcontrib><creatorcontrib>Gasson, Christian</creatorcontrib><creatorcontrib>Denniston, Kyle</creatorcontrib><creatorcontrib>Martin, Jovana</creatorcontrib><creatorcontrib>McElrath, Timothy</creatorcontrib><creatorcontrib>Timmins, Patrick F.</creatorcontrib><title>Lunchbox trial: A randomized phase III trial of cisplatin and irradiation followed by carboplatin and paclitaxel versus sandwich therapy of carboplatin and paclitaxel followed by irradiation then carboplatin and paclitaxel for advanced endometrial carcinoma</title><title>Gynecologic oncology</title><addtitle>Gynecol Oncol</addtitle><description>The objective was to compare sequencing strategies for treatment of advanced endometrial carcinoma.
Patients were eligible if they had FIGO 2009 Stage III or IVA endometrial carcinoma or Stage I or II serous or clear cell endometrial carcinoma and positive cytology. Patients were randomized to: Cisplatin 50 mg/m2 IV Days 1 and 29 plus radiation followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 4 cycles (chemoRT then chemo) vs. Carboplatin AUC 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles followed by radiation followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles (sandwich therapy). Futility analysis was planned. The primary objective was to determine if chemoRT then chemo improves recurrence-free survival (RFS) compared to sandwich therapy.
Of the 48 patients enrolled at 8 sites, 42 patients were eligible for futility analysis, and the trial was closed early. The median follow-up was 30.9 months. The 3-year RFS was 85.7% (95% confidence interval [CI], 62 to 95) in the chemoRT then chemo arm and 73.4% (95% CI, 43 to 89) in the sandwich therapy group (p = 0.58). The 3-year overall survival (OS) was 88.4% (95% CI, 61 to 97) in the chemoRT then chemo arm and 80.9% (95% CI, 51 to 93) in the sandwich therapy group (p = 0.55).
There was no observed significant difference between chemoRT then chemo compared to sandwich therapy in terms of RFS, OS, or adverse events, although the trial was underpowered and closed early due to low accrual.
•Randomized prospective trial results on chemotherapy and radiation sequencing in advanced endometrial cancer.•No observed difference in survival between chemoradiation followed by chemo and sandwich therapy in endometrial cancer.•Similar tolerability and location of recurrence using various sequencing strategies in advanced endometrial cancer.</description><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Carboplatin</subject><subject>Chemoradiation</subject><subject>Cisplatin</subject><subject>Endometrial cancer</subject><subject>Endometrial Neoplasms - drug therapy</subject><subject>Endometrial Neoplasms - radiotherapy</subject><subject>Female</subject><subject>Humans</subject><subject>Paclitaxel</subject><subject>Sandwich therapy</subject><issn>0090-8258</issn><issn>1095-6859</issn><issn>1095-6859</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kU1v1DAQhlMEokvhFyAhH3tJsJ04H0gcqoqPlVbiAmdr4oxZrxI72Mm24dfjbQraCz1Z9jzPjMZvkrxlNGOUle8P2fJzsS7jlOcZYxll_FmyYbQRaVmL5nmyobShac1FfZm8CuFAKc0j9DK5zGsqOGN0c3Gxm63at-6eTN5A_4HcEA-2c4P5jR0Z9xCQbLfbtUqcJsqEsYfJWBIxYryHzsSrs0S7vnd30WoXosC37owbQfVmgnvsyRF9mAMJ8fnOqD2Z9uhhXB56_986b34-NNr2ac8T6I5gVXTxtBiuq0RHGesGeJ280NAHfPN4XiU_Pn_6fvs13X37sr292aWqoMWUgqYUShQAuuVtxTVokVcdUwoKwZUqsahaoKKqapoLXhW8KnWlC9R5XTMo86vkeu07evdrxjDJwQSFfQ8W3Rwkr5u6EXlT8ojmK6q8C8GjlqM3A_hFMipP2cuDfMhenrKXjMkYa7TePQ6Y2wG7f87fsCPwcQUwrnk06GVQBk8_YzyqSXbOPDngD69DyMs</recordid><startdate>202401</startdate><enddate>202401</enddate><creator>Barlin, Joyce N.</creator><creator>Mahar, Barb</creator><creator>Ata, Ashar</creator><creator>Cormier, Beatrice</creator><creator>Michelin, David</creator><creator>Salani, Ritu</creator><creator>Backes, Floor</creator><creator>Levinson, Kimberly</creator><creator>Cantrell, Leigh Anne</creator><creator>Weinberg, Lori</creator><creator>Wagreich, Allison</creator><creator>Savage, Duncan</creator><creator>Gasson, Christian</creator><creator>Denniston, Kyle</creator><creator>Martin, Jovana</creator><creator>McElrath, Timothy</creator><creator>Timmins, Patrick F.</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202401</creationdate><title>Lunchbox trial: A randomized phase III trial of cisplatin and irradiation followed by carboplatin and paclitaxel versus sandwich therapy of carboplatin and paclitaxel followed by irradiation then carboplatin and paclitaxel for advanced endometrial carcinoma</title><author>Barlin, Joyce N. ; Mahar, Barb ; Ata, Ashar ; Cormier, Beatrice ; Michelin, David ; Salani, Ritu ; Backes, Floor ; Levinson, Kimberly ; Cantrell, Leigh Anne ; Weinberg, Lori ; Wagreich, Allison ; Savage, Duncan ; Gasson, Christian ; Denniston, Kyle ; Martin, Jovana ; McElrath, Timothy ; Timmins, Patrick F.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c404t-af00a6e5aafb2b72faf537d1cca452cc6e47ba05778035274276f7f4ef3881a63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Carboplatin</topic><topic>Chemoradiation</topic><topic>Cisplatin</topic><topic>Endometrial cancer</topic><topic>Endometrial Neoplasms - drug therapy</topic><topic>Endometrial Neoplasms - radiotherapy</topic><topic>Female</topic><topic>Humans</topic><topic>Paclitaxel</topic><topic>Sandwich therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Barlin, Joyce N.</creatorcontrib><creatorcontrib>Mahar, Barb</creatorcontrib><creatorcontrib>Ata, Ashar</creatorcontrib><creatorcontrib>Cormier, Beatrice</creatorcontrib><creatorcontrib>Michelin, David</creatorcontrib><creatorcontrib>Salani, Ritu</creatorcontrib><creatorcontrib>Backes, Floor</creatorcontrib><creatorcontrib>Levinson, Kimberly</creatorcontrib><creatorcontrib>Cantrell, Leigh Anne</creatorcontrib><creatorcontrib>Weinberg, Lori</creatorcontrib><creatorcontrib>Wagreich, Allison</creatorcontrib><creatorcontrib>Savage, Duncan</creatorcontrib><creatorcontrib>Gasson, Christian</creatorcontrib><creatorcontrib>Denniston, Kyle</creatorcontrib><creatorcontrib>Martin, Jovana</creatorcontrib><creatorcontrib>McElrath, Timothy</creatorcontrib><creatorcontrib>Timmins, Patrick F.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Gynecologic oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Barlin, Joyce N.</au><au>Mahar, Barb</au><au>Ata, Ashar</au><au>Cormier, Beatrice</au><au>Michelin, David</au><au>Salani, Ritu</au><au>Backes, Floor</au><au>Levinson, Kimberly</au><au>Cantrell, Leigh Anne</au><au>Weinberg, Lori</au><au>Wagreich, Allison</au><au>Savage, Duncan</au><au>Gasson, Christian</au><au>Denniston, Kyle</au><au>Martin, Jovana</au><au>McElrath, Timothy</au><au>Timmins, Patrick F.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Lunchbox trial: A randomized phase III trial of cisplatin and irradiation followed by carboplatin and paclitaxel versus sandwich therapy of carboplatin and paclitaxel followed by irradiation then carboplatin and paclitaxel for advanced endometrial carcinoma</atitle><jtitle>Gynecologic oncology</jtitle><addtitle>Gynecol Oncol</addtitle><date>2024-01</date><risdate>2024</risdate><volume>180</volume><spage>63</spage><epage>69</epage><pages>63-69</pages><issn>0090-8258</issn><issn>1095-6859</issn><eissn>1095-6859</eissn><abstract>The objective was to compare sequencing strategies for treatment of advanced endometrial carcinoma.
Patients were eligible if they had FIGO 2009 Stage III or IVA endometrial carcinoma or Stage I or II serous or clear cell endometrial carcinoma and positive cytology. Patients were randomized to: Cisplatin 50 mg/m2 IV Days 1 and 29 plus radiation followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 4 cycles (chemoRT then chemo) vs. Carboplatin AUC 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles followed by radiation followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles (sandwich therapy). Futility analysis was planned. The primary objective was to determine if chemoRT then chemo improves recurrence-free survival (RFS) compared to sandwich therapy.
Of the 48 patients enrolled at 8 sites, 42 patients were eligible for futility analysis, and the trial was closed early. The median follow-up was 30.9 months. The 3-year RFS was 85.7% (95% confidence interval [CI], 62 to 95) in the chemoRT then chemo arm and 73.4% (95% CI, 43 to 89) in the sandwich therapy group (p = 0.58). The 3-year overall survival (OS) was 88.4% (95% CI, 61 to 97) in the chemoRT then chemo arm and 80.9% (95% CI, 51 to 93) in the sandwich therapy group (p = 0.55).
There was no observed significant difference between chemoRT then chemo compared to sandwich therapy in terms of RFS, OS, or adverse events, although the trial was underpowered and closed early due to low accrual.
•Randomized prospective trial results on chemotherapy and radiation sequencing in advanced endometrial cancer.•No observed difference in survival between chemoradiation followed by chemo and sandwich therapy in endometrial cancer.•Similar tolerability and location of recurrence using various sequencing strategies in advanced endometrial cancer.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>38052110</pmid><doi>10.1016/j.ygyno.2023.11.012</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Gynecologic oncology, 2024-01, Vol.180, p.63-69 |
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| source | MEDLINE; Access via ScienceDirect (Elsevier) |
| subjects | Antineoplastic Combined Chemotherapy Protocols - adverse effects Carboplatin Chemoradiation Cisplatin Endometrial cancer Endometrial Neoplasms - drug therapy Endometrial Neoplasms - radiotherapy Female Humans Paclitaxel Sandwich therapy |
| title | Lunchbox trial: A randomized phase III trial of cisplatin and irradiation followed by carboplatin and paclitaxel versus sandwich therapy of carboplatin and paclitaxel followed by irradiation then carboplatin and paclitaxel for advanced endometrial carcinoma |
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