Carboplatin Paclitaxel Research Articles

Patient-reported outcomes in the subpopulation of patients with mismatch repair-deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer treated with dostarlimab plus chemotherapy compared with chemotherapy alone in the ENGOT-EN6-NSGO/GOG3031/RUBY trial

ObjectiveIn the ENGOT-EN6-NSGO/GOG3031/RUBY trial, dostarlimab+carboplatin–paclitaxel demonstrated significant improvement in progression free survival and a positive trend in overall survival compared with placebo+carboplatin–paclitaxel, with manageable toxicity, in patients with primary advanced...

Budget impact of dostarlimab plus carboplatin-paclitaxel for primary advanced or recurrent endometrial cancer from a third-party US payer perspective

Aim Dostarlimab plus carboplatin-paclitaxel (CP) significantly increased progression-free survival in patients with primary advanced or recurrent endometrial cancer (pA/rEC) vs CP alone in the RUBY trial (NCT03981796). This analysis estimated the per-member-per-month (PMPM) costs of introducing dostarlimab + CP as a treatment alternative from a third-party US payer perspective. Materials and methods A budget impact model was developed to estimate the costs of introducing dostarlimab + CP into commercial and Medicare health plans over a 3-year time horizon (2023–2025). Costs were sourced from relevant literature and US-specific databases and were calculated using epidemiology data, clinical inputs, treatment costs, and market share estimates. Clinical inputs were sourced from primary clinical trials for each respective treatment (i.e. dostarlimab + CP, CP, pembrolizumab, pembrolizumab plus lenvatinib, bevacizumab + CP, and pembrolizumab + CP). Current and future market shares assumed dostarlimab + CP reduced the market share of CP only. Analyses were performed in mismatch repair–deficient/microsatellite instability–high (dMMR/MSI-H) and overall populations using a US 2023 cost year. Results For a commercial plan, the model estimated (dMMR/MSI-H and overall populations) that 7 and 26 patients would be treated with dostarlimab + CP, respectively; average annual budget impacts per patient treated were $118,257 and $116,094; average budget impacts per patient treated per month (PPPM) were $9,855 and $9,675; average budget impacts PMPM were $0.02 and $0.06. For a Medicare plan, the model estimated that 28 and 93 patients, respectively, would be treated with dostarlimab + CP. Average annual budget impacts per patient treated and PPPM were the same as those for the commercial plan in both populations; average budget impacts PMPM were $0.07 and $0.22, respectively. Conclusions Introducing dostarlimab + CP as a first-line treatment for patients with pA/rEC results in minimal budget impact PMPM from a US third-party payer’s perspective. Together with the efficacy and safety results from RUBY, these results support the use of dostarlimab + CP as a treatment option.

869P Results of the multicenter phase II FRAIL-IMMUNE trial evaluating the efficacy and safety of durvalumab (D) combined with weekly paclitaxel carboplatin in 1st-line in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) not eligible to cisplatin

869P Results of the multicenter phase II FRAIL-IMMUNE trial evaluating the efficacy and safety of durvalumab (D) combined with weekly paclitaxel carboplatin in 1st-line in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) not eligible to cisplatin

751P Safety and tolerability of durvalumab (D) + carboplatin/paclitaxel (CP) + bevacizumab (B) followed by D, B + olaparib (O) maintenance (mtx) in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) without a tumour BRCA1/BRCA2 mutation (non-tBRCAm) in the phase III DUO-O trial

751P Safety and tolerability of durvalumab (D) + carboplatin/paclitaxel (CP) + bevacizumab (B) followed by D, B + olaparib (O) maintenance (mtx) in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) without a tumour BRCA1/BRCA2 mutation (non-tBRCAm) in the phase III DUO-O trial

732P Durvalumab + carboplatin/paclitaxel (CP) followed by durvalumab ± olaparib as a first-line treatment for endometrial cancer (EC): Progression-free survival (PFS) by clinical factors in DUO-E

732P Durvalumab + carboplatin/paclitaxel (CP) followed by durvalumab ± olaparib as a first-line treatment for endometrial cancer (EC): Progression-free survival (PFS) by clinical factors in DUO-E

863P Safety and efficacy of four courses of pembrolizumab combined with carboplatin and albumin-binding paclitaxel versus two courses of neoadjuvant therapy in patients with resectable head and neck squamous cell carcinoma: An optimal efficacy study (prospective, two-arm, phase II)

863P Safety and efficacy of four courses of pembrolizumab combined with carboplatin and albumin-binding paclitaxel versus two courses of neoadjuvant therapy in patients with resectable head and neck squamous cell carcinoma: An optimal efficacy study (prospective, two-arm, phase II)

Antibody-Drug Conjugates: The New Treatment Approaches for Ovarian Cancer.

Ovarian cancer (OC), accounting for approximately 200,000 deaths worldwide annually, is a heterogeneous disease showing major differences in terms of its incidence, tumor behavior, and outcomes across histological subtypes. In OC, primary chemotherapy, paclitaxel carboplatin, bevacizumab, and PARP inhibitors have shown prolonged progression-free survival and a favorable overall response rate compared to conventional treatments. However, treatment options for platinum-resistant recurrence cases are limited, with no effective therapies that significantly prolong the prognosis. Recently, mirvetuximab soravtansine, an alpha-folate receptor (FRα)-targeted antibody-drug conjugate (ADC), was approved by the US Food and Drug Administration for patients with FRα-positive recurrent epithelial OC (EOC). This approval was based on a Phase II study, which demonstrated its efficacy in such patients. ADCs comprise an antibody, a linker, and a payload, representing new concept agents without precedence. Advanced clinical studies are developing ADCs for patients with OC, targeting solid tumors such as gynecologic cancer. Ongoing clinical trials are evaluating ADCs targeting FRα and human epidermal growth factor receptor 2, trophoblast cell surface antigen-2, sodium-dependent phosphate transport protein 2B, and cadherin-6 in Phase II/III studies. In this review, we summarize the existing evidence supporting the use of ADCs in OC, discuss ongoing clinical trials and preclinical studies, and explore the potential of these innovative agents to address the challenges in OC treatment.

Nab-paclitaxel plus platinum versus paclitaxel plus platinum as first-line therapy in patients with metastatic or recurrent cervical cancer

PurposeThis study aimed to assess the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus platinum versus paclitaxel plus platinum as first-line therapy in patients with metastatic or recurrent cervical cancer.MethodsBetween October 2020 and March 2022, consecutive patients with diagnosed with metastatic or recurrent cervical cancer were retrospectively recruited in our hospital. Fifty-four patients were treated with nab-paclitaxel plus cisplatin or carboplatin. Twenty-four patients were treated with paclitaxel plus cisplatin or carboplatin. A propensity score matching (PSM) analysis was done using a multivariable logistic regression model. The two groups were compared for objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) in the raw and matched dataset.ResultsThe nab-paclitaxel group showed a higher ORR than the paclitaxel group both in the raw dataset (72.2% vs. 45.8%; P = 0.025) and matched dataset (81.1% vs. 47.6%; P = 0.008). The median PFS was significantly longer in the nab-paclitaxel group than in the paclitaxel group both in the raw and matched dataset (12 vs. 7 months; P < 0.05). The median OS was not reached in the nab-paclitaxel group compared with 15 months in the paclitaxel group, with a trend toward prolongation. The most common toxicity was hematological adverse events, including grade 3–4 neutropenia, grade 3 anemia and thrombocytopenia in both groups and no statistical differences were observed between the groups (all P > 0.05).ConclusionCompared with paclitaxel plus platinum, nab-paclitaxel plus platinum may be an effective and tolerable option as first-line therapy for patients with metastatic or recurrent cervical cancer.

Overall survival in patients with endometrial cancer treated with dostarlimab plus carboplatin–paclitaxel in the randomized ENGOT-EN6/GOG-3031/RUBY trial

Part 1 of the RUBY trial (NCT03981796) evaluated dostarlimab plus carboplatin-paclitaxel compared with placebo plus carboplatin-paclitaxel in patients with primary advanced or recurrent endometrial cancer (EC). At the first interim analysis, the trial met one of its dual primary endpoints with statistically significant progression-free survival benefits in the mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) and overall populations. Overall survival (OS) results are reported from the second interim analysis. RUBY is a phase III, global, double-blind, randomized, placebo-controlled trial. Part 1 of RUBY enrolled eligible patients with primary advanced stage III or IV or first recurrent EC who were randomly assigned (1 : 1) to receive either dostarlimab (500 mg) or placebo, plus carboplatin-paclitaxel every 3 weeks for 6 cycles followed by dostarlimab (1000 mg) or placebo every 6 weeks for up to 3 years. OS was a dual primary endpoint. A total of 494 patients were randomized (245 in the dostarlimab arm; 249 in the placebo arm). In the overall population, with 51% maturity, RUBY met the dual primary endpoint for OS at this second interim analysis, with a statistically significant reduction in the risk of death [hazard ratio (HR)= 0.69, 95% confidence interval (CI) 0.54-0.89, P= 0.0020] in patients treated with dostarlimab plus carboplatin-paclitaxel versus carboplatin-paclitaxel alone. The risk of death was lower in the dMMR/MSI-H population (HR= 0.32, 95% CI 0.17-0.63, nominal P= 0.0002) and a trend in favor of dostarlimab was seen in the mismatch repair-proficient/microsatellite stable population (HR= 0.79, 95% CI 0.60-1.04, nominal P= 0.0493). The safety profile for dostarlimab plus carboplatin-paclitaxel was consistent with the first interim analysis. Dostarlimab in combination with carboplatin-paclitaxel demonstrated a statistically significant and clinically meaningful OS benefit in the overall population of patients with primary advanced or recurrent EC while demonstrating an acceptable safety profile.

A phase III randomized, open-label study to establish the superiority of triple oral metronomic therapy (OMCT) used in addition to chemotherapy regimen (paclitaxel + carboplatin) over chemotherapy alone for the treatment of advanced unresectable head and neck cancer squamous cell cancer (HNSCC).

LBA6053 Background: Advanced HNSCC has poor outcomes and limited treatment options, especially in resource-constrained settings. Immunotherapy is affordable for less than 5% of patients in lower-middle-income countries (LMICs). Triple OMCT, employing low-dose continuous chemotherapy, shows promise, but its safety and efficacy along with chemotherapy remain unproven. We aimed to assess whether the addition of OMCT to first-line chemotherapy can improve overall survival (OS) as compared to chemotherapy alone. Methods: This phase 3 randomized, prospective, open-label, superiority design study enrolled patients with advanced HNSCC who were planned for palliative intent platinum-based chemotherapy. The patients were stratified for the site of the tumor and ECOG PS, and were randomly assigned 1:1 to receive either triple OMCT (Erlotinib 150 mg OD, Celecoxib 200 mg BD and Methotrexate 9mg/m2 once weekly) in addition to 3-weekly paclitaxel carboplatin (PC) chemotherapy (Arm A) or, PC chemotherapy alone (Arm B). Sample size calculation assumed no OS improvement with OMCT+PC (5% type I error, 80% type II error). The primary endpoint was OS, while secondary endpoints included PFS, quality of life (QoL) assessments, and safety. OS and PFS were analyzed via Kaplan-Meier and log-rank test; HR estimated via Cox proportional hazard models. QoL was assessed using EORTC QLQ-C30. The study was approved by Institutional Ethics Committee and registered with the Clinical Trials Registry India (CTRI/2022/10/046520). Results: Between Nov 02, 2022, and Dec 20, 2023, 238 patients were randomly assigned with 119 in each arm. Median age was 47 years, with 97.8% being males, and 78% of patients had ECOG PS 0-1. The median OS for patients in Arm A was 8.3 months (95% CI, 6.3-10.4) while it was 6.1 months (95% CI, 4.7-7.4), in Arm B (HR 0.63; 95% CI, 0.47–0.83; p=0.00011). The corresponding median PFS was 7.6 months (95% CI, 6.3-8.8) and 3.5 months (95% CI, 2.2-4.7) (HR, 2.79; 95% CI, 1.98-3.93; P&lt;0.000). Significant differences in EORTC-C30 were found for the physical functioning domain between baseline and 1-month follow-up visit. PC chemotherapy combined with triple OMCT showed good tolerability, with common toxicities including fatigue (40.3%), and hyponatremia (25.4%), similar to the incidence observed with PC chemotherapy alone. Conclusions: This study demonstrates that the addition of triple OMCT to paclitaxel and carboplatin chemotherapy is an effective and safe treatment option for patients with advanced HNSCC in platinum-sensitive settings. This treatment option is particularly valuable in LMICs, where cetuximab and pembrolizumab are not feasible. Clinical trial information: CTRI/2022/10/046520 . [Table: see text]

Dose dense doxorubicin plus cyclophosphamide in a modified KEYNOTE522 regimen for triple negative breast cancer

The KEYNOTE-522 (KN522) regimen for neoadjuvant treatment of triple negative breast cancer (TNBC) utilized q3week dosing for doxorubicin plus cyclophosphamide (AC); however, dose-dense AC (ddAC) has demonstrated superior overall survival (OS) compared to q3week AC in anthracycline and taxane-based regimens. We performed a retrospective analysis assessing the use of ddAC in KN522 and the impact of sequencing ddAC before or after carboplatin/paclitaxel (CbT) plus pembrolizumab on multiple outcomes. 128 patients with TNBC were included. Overall pathologic complete response (pCR) rate of 56%. Sequencing of ddAC vs CbT first showed no difference in pCR rate (ddAC 55% vs. CbT 58%, p = 0.77). However, ddAC first compared to CbT first correlated with a significant increase in the incidence of overall treatment delays (ddAC 70% vs. CbT 51%, p = 0.03), with cytopenias most frequent (ddAC 59% vs. CbT 31%, p = 0.001). ddAC in a modified KN522 regimen is safe, tolerable, and effective. Efficacy is comparable regardless of chemotherapy sequencing, but ddAC first is significantly associated with higher rates of treatment delays and cytopenias.

40MO First-line (1L) durvalumab + carboplatin/paclitaxel (CP) followed by durvalumab ± olaparib for endometrial cancer (EC) (DUO-E): Objective response rate (ORR), duration of response (DoR) and time to treatment discontinuation or death (TDT) by mismatch repair (MMR) status

40MO First-line (1L) durvalumab + carboplatin/paclitaxel (CP) followed by durvalumab ± olaparib for endometrial cancer (EC) (DUO-E): Objective response rate (ORR), duration of response (DoR) and time to treatment discontinuation or death (TDT) by mismatch repair (MMR) status

Durvalumab + carboplatin/paclitaxel (CP) followed by durvalumab ± olaparib as first-line treatment for newly diagnosed advanced or recurrent endometrial cancer (EC) in DUO-E: Results by BRCA1/BRCA2 mutation (BRCAm) status.

Durvalumab + carboplatin/paclitaxel (CP) followed by durvalumab ± olaparib as first-line treatment for newly diagnosed advanced or recurrent endometrial cancer (EC) in DUO-E: Results by <i>BRCA1</i>/<i>BRCA2</i> mutation (BRCAm) status.

43O Durvalumab (D) + carboplatin/paclitaxel (CP) + bevacizumab (B) followed by D, B + olaparib (O) maintenance (mtx) for newly diagnosed advanced ovarian cancer (AOC) without a tumour BRCA1/BRCA2 mutation (non-tBRCAm): Updated results from DUO-O

43O Durvalumab (D) + carboplatin/paclitaxel (CP) + bevacizumab (B) followed by D, B + olaparib (O) maintenance (mtx) for newly diagnosed advanced ovarian cancer (AOC) without a tumour BRCA1/BRCA2 mutation (non-tBRCAm): Updated results from DUO-O

Neoadjuvant sintilimab, albumin-bound paclitaxel, and carboplatin for locally advanced resectable esophageal squamous cell carcinoma: A prospective phase 2 study.

e16097 Background: Whether combined immunotherapy on the basis of neoadjuvant chemotherapy is beneficial for locally advanced esophageal squamous cell carcinoma (ESCC) remain to be inconclusive. This phase 2 study (ChineseClinical Trial Registry: ChiCTR2000041081) evaluate the efficacy and safety of neoadjuvant sintilimab, albumin-bound paclitaxel, and carboplatin in locally advanced ESCC. Methods: Patients with locally advanced ESCC (T2N+M0, T3N0-2M0, T4aN0-2M0, or no distant metastases, or viable or potentially viable) were enrolled and received 3 cycles of neoadjuvant sintilimab, albumin-bound paclitaxel, and carboplatin. Surgery was scheduled within four to six weeks of completing the neoadjuvant treatment. Three additional cycles of adjuvant sintilimab monotherapy or sintilimab plus chemotherapy were scheduled after a multidisciplinary discussion. The primary endpoint was the MPR rate. Results: From November 2020 to November 2021, twenty-four patients (median age: 64.5 years, men: 21/24,lower segment tumor location12/24,stage IV disease 15/24) were included in this study. All patients completed three cycles of neoadjuvant treatment and surgery. The median dose intensities for sintilimab, carboplatin and albumin-bound paclitaxel were 100% (range, 66.7–105.0%), 98.4% (range, 64.1–104.0%), and 100% (range, 38.1–105.8%), respectively. The R0 resection rate was 100%. The pCR rate and MPR rate was 33.3% and 41.7%. Among the 10 patients with PD-L1 CPS of ≥1, the pCR and MPR rates were 40% and 50%. 20 (83.1%) had TNM downstaging. The median DFS and median OS had not been reached yet, 500 days DFS and OS rate was 85.3% (95%CI 85.4%-97.2%) and 94.1% (95%CI 94.8%-100.0%). PD-L1 protein expression showed a higher life expectancy trend in the post-neoadjuvant therapy esophageal tissue samples than in the pre-therapy samples. The most common grade 3-4 treatment-related adverse events were anemia (29.2%), increased gamma-glutamyl transferase level (4.2%) and hyponatremia (4.2%). Emergency reoperation and intensive care were not required, and there were no postoperative mortalities. Conclusions: Neoadjuvant sintilimab, albumin-bound paclitaxel, and carboplatin preliminarily demonstrate encouraging clinical benefits and acceptable safety. Preoperative immunotherapy combined with chemotherapy alters the immune microenvironment of locally advanced resectable ESCC. Clinical trial information: ChiCTR2000041081.

Abstract PO2-03-12: Dose-Dense Doxorubicin plus Cyclophosphamide (ddAC) and Impact of Chemotherapy Sequence in a Modified KEYNOTE-522 Regimen for Neoadjuvant Treatment of Triple Negative Breast Cancer: Real World Experience

Abstract Background: Standard of care systemic treatment for early stage triple negative breast cancer (TNBC) consists of neoadjuvant chemoimmunotherapy based upon the results of KEYNOTE 522 (KN-522). The KN522 regimen utilized q3week dosing for doxorubicin plus cyclophosphamide (AC); however, dose-dense AC (ddAC) has shown superior OS compared to q3week AC in anthracycline and taxane-based regimens (per CALGB 9741 and EBCTCG analyses). We now present a retrospective study of patients treated with ddAC in a modified KN-522 regimen and report real world feasibility, safety, and efficacy endpoints, including exploration of whether sequencing ddAC before or after carboplatin/paclitaxel (CbT) plus pembrolizumab impacts outcome. Methods: Patients with TNBC treated at MSK from August 2021 to September 2022 with a preoperative KN-522 regimen were eligible for inclusion. Clinicopathological and demographic data were obtained from chart review. The primary goal of this study was to describe pathologic complete response (PCR) rate, incidence of treatment-related toxicities resulting in treatment delays, and type of toxicity. Treatment delays for toxicity were defined as a &amp;gt;1 week delay in treatment or discontinuation of a treatment regimen component due to a medical reason. Exploratory analysis was conducted to assess efficacy and toxicity of ddAC before or after CbT as well as rate of GCSF usage with CbT. Baseline characteristics, incidence and type of delays, and treatment outcomes were compared between ddAC first and CbT first using two sample non-parametric tests. Results: 129 TNBC patients met eligibility as defined above. Median age of diagnosis was 50. Clinical stage at diagnosis: Stage I 6%, Stage II 83%, and Stage III 11%. 128 patients received ddAC and 1 patient received AC q3week. Of the 128 patients, 54% received ddAC first while 46% received CbT first. Overall PCR rate of 56%. Treatment-related toxicity leading to chemotherapy delays was 61% and immunotherapy delays was 30%. Most chemotherapy delays were due to cytopenias (79%), with neutropenia (66%) most common. Adrenal insufficiency (4%) and hepatitis (5%) were the most common immune-related toxicities leading to delays. Overall, PCR rate was not affected by chemotherapy delays (No Delay 50% vs. Delay 60%, RR 0.83, 95%CI 0.60-1.15, p=0.25) or immunotherapy delays (No Delay 56% vs. Delay 58%, RR 0.96, 95%CI 0.69-1.33, p=0.81). Exploratory analysis comparing sequencing of ddAC vs CbT first showed incidence of CbT delays was 58% in patients treated with ddAC first and 27% in CbT first. Incidence of ddAC delays was 3% in patients treated with ddAC first and 7% in CbT first. Incidence of delays in both ddAC and CbT was 9% in ddAC first and 10% in CbT first. There was no difference in PCR rate (ddAC 55% vs. CbT 58%, RR 0.96, 95%CI 0.70-1.30, p=0.77) or rate of immunotherapy delays (ddAC 32% vs. CbT 34%, RR 0.93, 95%CI 0.55-1.57, p=0.79) based on sequence of chemotherapy. However, ddAC first compared to CbT first correlated with a significant increase in the incidence of overall treatment delays (ddAC 70% vs. CbT 51%, RR 1.37, 95%CI 1.02-1.84, p=0.03), use of GCSF during CbT (ddAC 55% vs. CbT 34%, RR 1.60, 95%CI 1.06-2.45, p=0.02), and treatment-limiting cytopenias at any time point before surgery (ddAC 59% vs. CbT 31%, RR 1.95, 95%CI 1.26-3.00, p=0.001). Conclusions: These real world data support the feasibility and tolerability of ddAC in a modified KN522 regimen. Exploratory analysis on sequencing of ddAC vs. CbT first in this regimen suggests that efficacy is comparable, yet ddAC first is significantly associated with higher rates of treatment delays and cytopenias. Overall, our experience suggests ddAC is a safe and viable modification to KN-522, and sequencing ddAC after CbT may reduce the risk of treatment induced cytopenias. Citation Format: Nicholas Mai, Sara Myers, Sherry Shen, Stephanie Downs-Canner, Yuan Chen, Tiffany Traina, Nour Abuhadra. Dose-Dense Doxorubicin plus Cyclophosphamide (ddAC) and Impact of Chemotherapy Sequence in a Modified KEYNOTE-522 Regimen for Neoadjuvant Treatment of Triple Negative Breast Cancer: Real World Experience [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-03-12.

Abstract PO5-13-01: An App-Based Approach to Monitor Chemotherapy Symptoms

Abstract Introduction Patient-Reported Outcome Measures (PROM’s) are important tools that can enhance symptom management and patient quality of life in cancer treatment. Despite well-documented benefits, they are not often employed in routine care. This study aims to investigate the feasibility and acceptance of the integration of a dedicated mobile app for real-time symptom tracking and intervention using PROM’s among patients undergoing neoadjuvant or adjuvant chemotherapy for breast cancer. Methods We developed a dedicated mobile app for tracking PROM’s utilizing the NCI PRO-CTCAE to monitor 12 common chemotherapy-related symptoms. We aimed to evaluate patient acceptance and clinical feasibility of the app. Patient responses were directed to a personalized dashboard for designed for the clinical treatment team. We determined self-reported grade 3 or 4 vomiting, diarrhea, constipation, shortness of breath, cough, or peripheral neuropathy and grade 4 mucositis, nausea, or pain as symptoms severe enough to trigger an automatic alert requiring a phone call from our nursing staff for support. Each questionnaire generated up to 1 alert regardless of the number of severe symptoms. Symptomatic patients also received personalized automated instructions and video links for symptom management regardless of the severity of their symptoms. In response to staff feedback during the study, we added an additional assessment to determine whether patients with severe symptoms were interested in direct contact from the clinical staff when alerts were triggered. At baseline patients reported if they felt they were skillful at using smartphone apps. Quality of life, psychological and emotional health measures were collected at baseline, and weeks 6, 12, and 18. Categorical variable were described using percentages and compared using the chi squared test. Statistical analyses were performed by SPSS. Results: At the time of this analysis, 58 patients were recruited and found eligible for the study. All 58 patients self-reported as skilled with the use of smartphone apps. Eighteen patients (31%) withdrew from the study after receiving at least one questionnaire and their data was included up to their point of withdrawal. The different chemotherapy regimens given in the study are shown in table 1. Out of 772 questionnaires sent, 404 were returned, resulting in a 52% completion rate. These 404 completed questionnaires generated 126 (31%) alerts. After including feedback on the interest of direct contact from our nursing staff to manage alarming symptoms, only 23/102 (22.5%) alerts required clinical contact. Twenty-one patients (36%) did not complete even a single questionnaire. For the 37 (64%) patients who completed at least 1 questionnaire the completion rate was 74%. There was no significant difference in the alert rate of completed questionnaires between patients receiving TCHP, TC-AC-Pembro, and AC-T (38%, 38%, 29% p=NS). TC triggered significantly less alerts than AC-T (11% vs 29% p=0.01). Conclusion: The interim results of our ongoing study highlight the potential of a mobile app in real-time monitoring of chemotherapy-related symptoms. Our results suggest symptom monitoring using a dedicated mobile app is both acceptable and feasible for both patients and clinical personnel. The digital approach also seems effective in triggering alerts for severe symptoms, facilitating timely intervention. However, most alerts did not necessitate direct clinical contact, underscoring the role these interventions may play in allowing for patient self-care. However, over a third of patients did not utilize the app at all, emphasizing the need for further research examining the factors influencing the utilization of this technology for symptom monitoring. As the study continues, we hope to gain insights that can simplify and improve patient and clinician interaction with this tool, potentially improving symptom management for adjuvant breast cancer. Table 1 Chemotherapy Regimens DD AC-T dose dense doxorubicin cyclophosphamide paclitaxel, TCHP docetaxel carboplatin trastuzumab pertuzumab, TC-AC-Pembro paclitaxel carboplatin doxorubicin cyclophosphamide pembrolizumab, TC docetaxel cyclophosphamide,DD AC-T weekly dose dense doxorubicin cyclophosphamide paclitaxel weekly, TH paclitaxel trastuzumab, AC-THP doxorubicin cyclophosphamide paclitaxel trastuzumab pertuzumab, AC-TC doxorubicin cyclophosphamide paclitaxel carboplatin Citation Format: Opher Globus, Tal Sella, Amit Itay, Tali Shapira, Raisa Gold, Tami Modiano, Cecilia Oedegaard, Maya Krikli, Michal Bakalenik-Gavry, Beatrice Shaham, Alex Galper, Einav Nili-Gal Yam. An App-Based Approach to Monitor Chemotherapy Symptoms [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-13-01.

Treatment Strategies for Non-Small-Cell Lung Cancer with Comorbid Respiratory Disease; Interstitial Pneumonia, Chronic Obstructive Pulmonary Disease, and Tuberculosis.

Non-small cell lung cancer (NSCLC) patients are often complicated by other respiratory diseases, including interstitial pneumonia (IP), chronic obstructive pulmonary disease (COPD), and pulmonary tuberculosis (TB), and the management of which can be problematic. NSCLC patients with IP sometimes develop fatal acute exacerbation induced by pharmacotherapy, and the establishment of a safe treatment strategy is desirable. For advanced NSCLC with IP, carboplatin plus nanoparticle albumin-bound paclitaxel is a relatively safe and effective first-line treatment option. Although the safety of immune checkpoint inhibitors (ICIs) for these populations remains controversial, ICIs have the potential to provide long-term survival. The severity of COPD is an important prognostic factor in NSCLC patients. Although COPD complications do not necessarily limit treatment options, it is important to select drugs with fewer side effects on the heart and blood vessels as well as the lungs. Active TB is complicated by 2-5% of NSCLC cases during their disease course. Since pharmacotherapy, especially ICIs, reportedly induces the development of TB, the possibility of developing TB should always be kept in mind during NSCLC treatment. To date, there is no coherent review article on NSCLC with these pulmonary complications. This review article summarizes the current evidence and discusses future prospects for treatment strategies for NSCLC patients complicated with IP, severe COPD, and TB.

Statement of the Uterus Commission of the Gynecological Oncology Working Group (AGO) on Neoadjuvant Chemotherapy Prior to Definitive Radiochemotherapy in Patients with Locally Advanced Cervical Cancer.

The presentation of the results of the prospective randomized international multicenter GCIG INTERLACE trial at the 2023 congress of the European Society of Medical Oncology (ESMO) is likely to change the therapy for locally advanced cervical cancer. In the GCIG INTERLACE trial, six cycles of neoadjuvant chemotherapy administered weekly and consisting of carboplatin AUC2 and paclitaxel 80 mg/m 2 followed by definitive radiochemotherapy with pelvic radiotherapy (40 - 50.4Gray) and cisplatin (40 mg/m 2 once a week for 5 weeks) and brachytherapy (total dose EQD2 at least 78 Gy at point A) (experimental arm) were compared with definitive radiochemotherapy alone (standard arm) in patients with locally advanced cervical cancer (Fédération Internationale de Gynécologie et d'Obstétrique [FIGO] 2008 stage IB1/node positive, IB2, II, IIIB and IVA) and was found to be significantly superior with significantly longer recurrence-free survival (hazard ratio [HR] 0.65; 95% confidence interval [CI] 0.64 - 0.91; p = 0.013) and significantly longer overall survival rates (HR 0.61; 95% CI: 0.40 - 0.91; p = 0.04) after 5 years' follow-up. After considering the results of the GCIG INTERLACE trial published at the congress, the Uterus Commission of the AGO is of the opinion that neoadjuvant chemotherapy with carboplatin AUC2 and paclitaxel 80 mg/m 2 d1, q7, x6 may be offered to patients with locally advanced cervical cancer (FIGO stage IB1/node positive, IB2, II, IIIB and IVA) in addition to the current standard therapy after the patient has been informed about the risks, with the decision taken on a case-by-case basis. However, before this approach can be discussed at guideline level or defined as the new therapy standard, it will be necessary to wait until the data from the full publication are available.

The PARTNER trial of neoadjuvant olaparib with chemotherapy in triple-negative breast cancer

PARTNER is a prospective, phase II–III, randomized controlled clinical trial that recruited patients with triple-negative breast cancer1,2, who were germline BRCA1 and BRCA2 wild type3. Here we report the results of the trial. Patients (n = 559) were randomized on a 1:1 basis to receive neoadjuvant carboplatin–paclitaxel with or without 150 mg olaparib twice daily, on days 3 to 14, of each of four cycles (gap schedule olaparib, research arm) followed by three cycles of anthracycline-based chemotherapy before surgery. The primary end point was pathologic complete response (pCR)4, and secondary end points included event-free survival (EFS) and overall survival (OS)5. pCR was achieved in 51% of patients in the research arm and 52% in the control arm (P = 0.753). Estimated EFS at 36 months in the research and control arms was 80% and 79% (log-rank P > 0.9), respectively; OS was 90% and 87.2% (log-rank P = 0.8), respectively. In patients with pCR, estimated EFS at 36 months was 90%, and in those with non-pCR it was 70% (log-rank P < 0.001), and OS was 96% and 83% (log-rank P < 0.001), respectively. Neoadjuvant olaparib did not improve pCR rates, EFS or OS when added to carboplatin–paclitaxel and anthracycline-based chemotherapy in patients with triple-negative breast cancer who were germline BRCA1 and BRCA2 wild type. ClinicalTrials.gov ID: NCT03150576.