Premastectomy Radiotherapy and Immediate Breast Reconstruction: A Randomized Clinical Trial
Premastectomy radiotherapy (PreMRT) is a new treatment sequence to avoid the adverse effects of radiotherapy on the final breast reconstruction while achieving the benefits of immediate breast reconstruction (IMBR). To evaluate outcomes among patients who received PreMRT and regional nodal irradiati...
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Published in | JAMA network open Vol. 7; no. 4; p. e245217 |
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Abstract | Premastectomy radiotherapy (PreMRT) is a new treatment sequence to avoid the adverse effects of radiotherapy on the final breast reconstruction while achieving the benefits of immediate breast reconstruction (IMBR).
To evaluate outcomes among patients who received PreMRT and regional nodal irradiation (RNI) followed by mastectomy and IMBR.
This was a phase 2 single-center randomized clinical trial conducted between August 3, 2018, and August 2, 2022, evaluating the feasibility and safety of PreMRT and RNI (including internal mammary lymph nodes). Patients with cT0-T3, N0-N3b breast cancer and a recommendation for radiotherapy were eligible.
This trial evaluated outcomes after PreMRT followed by mastectomy and IMBR. Patients were randomized to receive either hypofractionated (40.05 Gy/15 fractions) or conventionally fractionated (50 Gy/25 fractions) RNI.
The primary outcome was reconstructive failure, defined as complete autologous flap loss. Demographic, treatment, and outcomes data were collected, and associations between multiple variables and outcomes were evaluated. Analysis was performed on an intent-to-treat basis.
Fifty patients were enrolled. Among 49 evaluable patients, the median age was 48 years (range, 31-72 years), and 46 patients (94%) received neoadjuvant systemic therapy. Twenty-five patients received 50 Gy in 25 fractions to the breast and 45 Gy in 25 fractions to regional nodes, and 24 patients received 40.05 Gy in 15 fractions to the breast and 37.5 Gy in 15 fractions to regional nodes, including internal mammary lymph nodes. Forty-eight patients underwent mastectomy with IMBR, at a median of 23 days (IQR, 20-28.5 days) after radiotherapy. Forty-one patients had microvascular autologous flap reconstruction, 5 underwent latissimus dorsi pedicled flap reconstruction, and 2 had tissue expander placement. There were no complete autologous flap losses, and 1 patient underwent tissue expander explantation. Eight of 48 patients (17%) had mastectomy skin flap necrosis of the treated breast, of whom 1 underwent reoperation. During follow-up (median, 29.7 months [range, 10.1-65.2 months]), there were no locoregional recurrences or distant metastasis.
This randomized clinical trial found PreMRT and RNI followed by mastectomy and microvascular autologous flap IMBR to be feasible and safe. Based on these results, a larger randomized clinical trial of hypofractionated vs conventionally fractionated PreMRT has been started (NCT05774678).
ClinicalTrials.gov Identifier: NCT02912312. |
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AbstractList | Premastectomy radiotherapy (PreMRT) is a new treatment sequence to avoid the adverse effects of radiotherapy on the final breast reconstruction while achieving the benefits of immediate breast reconstruction (IMBR).
To evaluate outcomes among patients who received PreMRT and regional nodal irradiation (RNI) followed by mastectomy and IMBR.
This was a phase 2 single-center randomized clinical trial conducted between August 3, 2018, and August 2, 2022, evaluating the feasibility and safety of PreMRT and RNI (including internal mammary lymph nodes). Patients with cT0-T3, N0-N3b breast cancer and a recommendation for radiotherapy were eligible.
This trial evaluated outcomes after PreMRT followed by mastectomy and IMBR. Patients were randomized to receive either hypofractionated (40.05 Gy/15 fractions) or conventionally fractionated (50 Gy/25 fractions) RNI.
The primary outcome was reconstructive failure, defined as complete autologous flap loss. Demographic, treatment, and outcomes data were collected, and associations between multiple variables and outcomes were evaluated. Analysis was performed on an intent-to-treat basis.
Fifty patients were enrolled. Among 49 evaluable patients, the median age was 48 years (range, 31-72 years), and 46 patients (94%) received neoadjuvant systemic therapy. Twenty-five patients received 50 Gy in 25 fractions to the breast and 45 Gy in 25 fractions to regional nodes, and 24 patients received 40.05 Gy in 15 fractions to the breast and 37.5 Gy in 15 fractions to regional nodes, including internal mammary lymph nodes. Forty-eight patients underwent mastectomy with IMBR, at a median of 23 days (IQR, 20-28.5 days) after radiotherapy. Forty-one patients had microvascular autologous flap reconstruction, 5 underwent latissimus dorsi pedicled flap reconstruction, and 2 had tissue expander placement. There were no complete autologous flap losses, and 1 patient underwent tissue expander explantation. Eight of 48 patients (17%) had mastectomy skin flap necrosis of the treated breast, of whom 1 underwent reoperation. During follow-up (median, 29.7 months [range, 10.1-65.2 months]), there were no locoregional recurrences or distant metastasis.
This randomized clinical trial found PreMRT and RNI followed by mastectomy and microvascular autologous flap IMBR to be feasible and safe. Based on these results, a larger randomized clinical trial of hypofractionated vs conventionally fractionated PreMRT has been started (NCT05774678).
ClinicalTrials.gov Identifier: NCT02912312. Premastectomy radiotherapy (PreMRT) is a new treatment sequence to avoid the adverse effects of radiotherapy on the final breast reconstruction while achieving the benefits of immediate breast reconstruction (IMBR).ImportancePremastectomy radiotherapy (PreMRT) is a new treatment sequence to avoid the adverse effects of radiotherapy on the final breast reconstruction while achieving the benefits of immediate breast reconstruction (IMBR).To evaluate outcomes among patients who received PreMRT and regional nodal irradiation (RNI) followed by mastectomy and IMBR.ObjectiveTo evaluate outcomes among patients who received PreMRT and regional nodal irradiation (RNI) followed by mastectomy and IMBR.This was a phase 2 single-center randomized clinical trial conducted between August 3, 2018, and August 2, 2022, evaluating the feasibility and safety of PreMRT and RNI (including internal mammary lymph nodes). Patients with cT0-T3, N0-N3b breast cancer and a recommendation for radiotherapy were eligible.Design, Setting, and ParticipantsThis was a phase 2 single-center randomized clinical trial conducted between August 3, 2018, and August 2, 2022, evaluating the feasibility and safety of PreMRT and RNI (including internal mammary lymph nodes). Patients with cT0-T3, N0-N3b breast cancer and a recommendation for radiotherapy were eligible.This trial evaluated outcomes after PreMRT followed by mastectomy and IMBR. Patients were randomized to receive either hypofractionated (40.05 Gy/15 fractions) or conventionally fractionated (50 Gy/25 fractions) RNI.InterventionThis trial evaluated outcomes after PreMRT followed by mastectomy and IMBR. Patients were randomized to receive either hypofractionated (40.05 Gy/15 fractions) or conventionally fractionated (50 Gy/25 fractions) RNI.The primary outcome was reconstructive failure, defined as complete autologous flap loss. Demographic, treatment, and outcomes data were collected, and associations between multiple variables and outcomes were evaluated. Analysis was performed on an intent-to-treat basis.Main Outcome and MeasuresThe primary outcome was reconstructive failure, defined as complete autologous flap loss. Demographic, treatment, and outcomes data were collected, and associations between multiple variables and outcomes were evaluated. Analysis was performed on an intent-to-treat basis.Fifty patients were enrolled. Among 49 evaluable patients, the median age was 48 years (range, 31-72 years), and 46 patients (94%) received neoadjuvant systemic therapy. Twenty-five patients received 50 Gy in 25 fractions to the breast and 45 Gy in 25 fractions to regional nodes, and 24 patients received 40.05 Gy in 15 fractions to the breast and 37.5 Gy in 15 fractions to regional nodes, including internal mammary lymph nodes. Forty-eight patients underwent mastectomy with IMBR, at a median of 23 days (IQR, 20-28.5 days) after radiotherapy. Forty-one patients had microvascular autologous flap reconstruction, 5 underwent latissimus dorsi pedicled flap reconstruction, and 2 had tissue expander placement. There were no complete autologous flap losses, and 1 patient underwent tissue expander explantation. Eight of 48 patients (17%) had mastectomy skin flap necrosis of the treated breast, of whom 1 underwent reoperation. During follow-up (median, 29.7 months [range, 10.1-65.2 months]), there were no locoregional recurrences or distant metastasis.ResultsFifty patients were enrolled. Among 49 evaluable patients, the median age was 48 years (range, 31-72 years), and 46 patients (94%) received neoadjuvant systemic therapy. Twenty-five patients received 50 Gy in 25 fractions to the breast and 45 Gy in 25 fractions to regional nodes, and 24 patients received 40.05 Gy in 15 fractions to the breast and 37.5 Gy in 15 fractions to regional nodes, including internal mammary lymph nodes. Forty-eight patients underwent mastectomy with IMBR, at a median of 23 days (IQR, 20-28.5 days) after radiotherapy. Forty-one patients had microvascular autologous flap reconstruction, 5 underwent latissimus dorsi pedicled flap reconstruction, and 2 had tissue expander placement. There were no complete autologous flap losses, and 1 patient underwent tissue expander explantation. Eight of 48 patients (17%) had mastectomy skin flap necrosis of the treated breast, of whom 1 underwent reoperation. During follow-up (median, 29.7 months [range, 10.1-65.2 months]), there were no locoregional recurrences or distant metastasis.This randomized clinical trial found PreMRT and RNI followed by mastectomy and microvascular autologous flap IMBR to be feasible and safe. Based on these results, a larger randomized clinical trial of hypofractionated vs conventionally fractionated PreMRT has been started (NCT05774678).Conclusions and RelevanceThis randomized clinical trial found PreMRT and RNI followed by mastectomy and microvascular autologous flap IMBR to be feasible and safe. Based on these results, a larger randomized clinical trial of hypofractionated vs conventionally fractionated PreMRT has been started (NCT05774678).ClinicalTrials.gov Identifier: NCT02912312.Trial RegistrationClinicalTrials.gov Identifier: NCT02912312. This randomized clinical trial evaluates outcomes among patients who received premastectomy radiotherapy and regional nodal irradiation followed by mastectomy and immediate breast reconstruction. Importance Premastectomy radiotherapy (PreMRT) is a new treatment sequence to avoid the adverse effects of radiotherapy on the final breast reconstruction while achieving the benefits of immediate breast reconstruction (IMBR). Objective To evaluate outcomes among patients who received PreMRT and regional nodal irradiation (RNI) followed by mastectomy and IMBR. Design, Setting, and Participants This was a phase 2 single-center randomized clinical trial conducted between August 3, 2018, and August 2, 2022, evaluating the feasibility and safety of PreMRT and RNI (including internal mammary lymph nodes). Patients with cT0-T3, N0-N3b breast cancer and a recommendation for radiotherapy were eligible. Intervention This trial evaluated outcomes after PreMRT followed by mastectomy and IMBR. Patients were randomized to receive either hypofractionated (40.05 Gy/15 fractions) or conventionally fractionated (50 Gy/25 fractions) RNI. Main Outcome and Measures The primary outcome was reconstructive failure, defined as complete autologous flap loss. Demographic, treatment, and outcomes data were collected, and associations between multiple variables and outcomes were evaluated. Analysis was performed on an intent-to-treat basis. Results Fifty patients were enrolled. Among 49 evaluable patients, the median age was 48 years (range, 31-72 years), and 46 patients (94%) received neoadjuvant systemic therapy. Twenty-five patients received 50 Gy in 25 fractions to the breast and 45 Gy in 25 fractions to regional nodes, and 24 patients received 40.05 Gy in 15 fractions to the breast and 37.5 Gy in 15 fractions to regional nodes, including internal mammary lymph nodes. Forty-eight patients underwent mastectomy with IMBR, at a median of 23 days (IQR, 20-28.5 days) after radiotherapy. Forty-one patients had microvascular autologous flap reconstruction, 5 underwent latissimus dorsi pedicled flap reconstruction, and 2 had tissue expander placement. There were no complete autologous flap losses, and 1 patient underwent tissue expander explantation. Eight of 48 patients (17%) had mastectomy skin flap necrosis of the treated breast, of whom 1 underwent reoperation. During follow-up (median, 29.7 months [range, 10.1-65.2 months]), there were no locoregional recurrences or distant metastasis. Conclusions and Relevance This randomized clinical trial found PreMRT and RNI followed by mastectomy and microvascular autologous flap IMBR to be feasible and safe. Based on these results, a larger randomized clinical trial of hypofractionated vs conventionally fractionated PreMRT has been started ( NCT05774678 ). Trial Registration ClinicalTrials.gov Identifier: NCT02912312 |
Author | Singh, Puneet Chavez-MacGregor, Mariana Colen, Jessica S Qiao, Wei Shuck, John W Woodward, Wendy A Smith, Benjamin D Schaverien, Mark V Kuerer, Henry M Zacharia, Rensi Hoffman, Karen E Villa, Mark T Bloom, Elizabeth S Mitchell, Melissa P Tamirisa, Nina Tripathy, Debasish Ehlers, Richard A Largo, Rene D Clemens, Mark W Hwang, Rosa F Joyner, Melissa M Mericli, Alexander F Akay, Catherine L Chu, Carrie K |
AuthorAffiliation | 3 Division of Radiation Oncology, Department of Breast Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston 1 Division of Surgery, Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston 5 Division of Cancer Medicine, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston 4 Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston 2 Division of Surgery, Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston |
AuthorAffiliation_xml | – name: 1 Division of Surgery, Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston – name: 2 Division of Surgery, Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston – name: 4 Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston – name: 5 Division of Cancer Medicine, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston – name: 3 Division of Radiation Oncology, Department of Breast Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston |
Author_xml | – sequence: 1 givenname: Mark V surname: Schaverien fullname: Schaverien, Mark V organization: Division of Surgery, Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston – sequence: 2 givenname: Puneet surname: Singh fullname: Singh, Puneet organization: Division of Surgery, Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston – sequence: 3 givenname: Benjamin D surname: Smith fullname: Smith, Benjamin D organization: Division of Radiation Oncology, Department of Breast Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston – sequence: 4 givenname: Wei surname: Qiao fullname: Qiao, Wei organization: Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston – sequence: 5 givenname: Catherine L surname: Akay fullname: Akay, Catherine L organization: Division of Surgery, Department of Breast Surgical Oncology, The University of Texas MD 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Surgery, Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston – sequence: 11 givenname: Richard A surname: Ehlers fullname: Ehlers, Richard A organization: Division of Surgery, Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston – sequence: 12 givenname: Rosa F surname: Hwang fullname: Hwang, Rosa F organization: Division of Surgery, Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston – sequence: 13 givenname: Melissa M surname: Joyner fullname: Joyner, Melissa M organization: Division of Radiation Oncology, Department of Breast Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston – sequence: 14 givenname: Rene D surname: Largo fullname: Largo, Rene D organization: Division of Surgery, Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston – sequence: 15 givenname: Alexander F surname: Mericli fullname: Mericli, Alexander F organization: Division of Surgery, Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston – sequence: 16 givenname: Melissa P surname: Mitchell fullname: Mitchell, Melissa P organization: Division of Radiation Oncology, Department of Breast Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston – sequence: 17 givenname: John W surname: Shuck fullname: Shuck, John W organization: Division of Surgery, Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston – sequence: 18 givenname: Nina surname: Tamirisa fullname: Tamirisa, Nina organization: Division of Surgery, Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston – sequence: 19 givenname: Debasish surname: Tripathy fullname: Tripathy, Debasish organization: Division of Cancer Medicine, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston – sequence: 20 givenname: Mark T surname: Villa fullname: Villa, Mark T organization: Division of Surgery, Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston – sequence: 21 givenname: Wendy A surname: Woodward fullname: Woodward, Wendy A organization: Division of Surgery, Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston – sequence: 22 givenname: Rensi surname: Zacharia fullname: Zacharia, Rensi organization: Division of Radiation Oncology, Department of Breast Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston – sequence: 23 givenname: Henry M surname: Kuerer fullname: Kuerer, Henry M organization: Division of Surgery, Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston – sequence: 24 givenname: Karen E surname: Hoffman fullname: Hoffman, Karen E organization: Division of Radiation Oncology, Department of Breast Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston |
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Snippet | Premastectomy radiotherapy (PreMRT) is a new treatment sequence to avoid the adverse effects of radiotherapy on the final breast reconstruction while achieving... Importance Premastectomy radiotherapy (PreMRT) is a new treatment sequence to avoid the adverse effects of radiotherapy on the final breast reconstruction... This randomized clinical trial evaluates outcomes among patients who received premastectomy radiotherapy and regional nodal irradiation followed by mastectomy... |
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Title | Premastectomy Radiotherapy and Immediate Breast Reconstruction: A Randomized Clinical Trial |
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