Since the publication of this paper, the authors have reported that an incorrect version of Figure 1 was presented. The correct version of Figure 1 is provided.An amendment to this paper has been ...published and can be accessed via a link at the top of the paper.
AGO‐OVAR 12 investigated the effect of adding the oral triple angiokinase inhibitor nintedanib to standard front‐line chemotherapy for advanced ovarian cancer. At the primary analysis, nintedanib ...demonstrated significantly improved progression‐free survival (PFS; primary endpoint) compared with placebo. We report final results, including overall survival (OS). Patients with primary debulked International Federation of Gynaecology and Obstetrics (FIGO) stage IIB–IV newly diagnosed ovarian cancer were randomised 2:1 to receive carboplatin (area under the curve 5 or 6) plus paclitaxel (175 mg/m2) on day 1 every 3 weeks for six cycles combined with either nintedanib 200 mg or placebo twice daily on days 2–21 every 3 weeks for up to 120 weeks. Between December 2009 and July 2011, 1,366 patients were randomised (911 to nintedanib, 455 to placebo). Disease was considered as high risk (FIGO stage III with >1 cm residuum, or any stage IV) in 39%. At the final analysis, 605 patients (44%) had died. There was no difference in OS (hazard ratio 0.99, 95% confidence interval CI 0.83–1.17, p = 0.86; median 62.0 months with nintedanib vs. 62.8 months with placebo). Subgroup analyses according to stratification factors, clinical characteristics and risk status showed no OS difference between treatments. The previously reported PFS improvement seen with nintedanib did not translate into an OS benefit in the nonhigh‐risk subgroup. Updated PFS results were consistent with the primary analysis (hazard ratio 0.86, 95% CI 0.75–0.98; p = 0.029) favouring nintedanib. The safety profile was consistent with previous reports.
What's new?
Primary results from the randomised phase III AGO‐OVAR 12 trial comparing nintedanib (a triple angiokinase inhibitor) with placebo given in combination with chemotherapy and then continued as maintenance therapy in patients with newly diagnosed advanced ovarian carcinoma demonstrated a significant improvement in progression‐free survival with nintedanib. However, as reported in this paper, final overall survival (OS) results showed that the addition of nintedanib had no impact on OS. These results do not, therefore, support use of nintedanib in ovarian cancer.
Wichtige Studien vom ESMO 2023 Wörmann, Bernhard
Best practice onkologie,
12/2023, Volume:
18, Issue:
12
Journal Article
Peer reviewed
Ergebnisse Selpercatinib in der Erstlinientherapie des fortgeschrittenen, nichtkleinzelligen Lungenkarzinom mit Nachweis einer RET-Fusion Studie Risikogruppe N1 Therapie RR2 PFÜ3 ÜL5 LIBRETTO 431 ...NSCLC, RET+, Stadium IIIB-IV, nicht-plattenepithelial 212 Cis- oder Carboplatin + Pemetrexed +/− Pembrolizumab 65 11,2 – Selpercatinib 846 24,8 HR4 0,395 p < 0,0001 n. s.7 1N Anzahl Pat., 2RR Remissionsrate in %, 3PFÜ progressionsfreie Überlebenszeit, Median in Monaten, 4HR Hazard Ratio, 5ÜLZ Gesamtüberlebenszeit, Median in Monaten, 6Ergebnis für Neue Therapie,7n. s. nicht signifikant Zusammenfassung der Präsentation Zusammenfassung der Autoren. Ergebnisse Amivantamab plus Chemotherapie in der Erstlinientherapie des fortgeschrittenen nichtkleinzelligen Lungenkarzinoms mit EGFR Exon 20 Insertionen Studie Risikogruppe N1 Therapie RR2 PFÜ3 ÜL5 PAPILLON NSCLC, fortgeschritten, EGFR Exon 20 Insertionen, nicht vorbehandelt 303 Carboplatin + Pemetrexed 47 6,7 24,4 Carboplatin + Pemetrexed + Amivantamab 736 11,4 n. e. 7 HR4 0,395 HR 0,675 p < 0,0001 p = 0,106 1N Anzahl Pat., 2RR Remissionsrate in %, 3PFÜ progressionsfreie Überlebenszeit, Median in Monaten, 4HR Hazard Ratio, 5ÜLZ Gesamtüberlebenszeit, Median in Monaten, 6Ergebnis für Neue Therapie,7n. Ergebnisse Perioperative Therapie mit platinbasierter Chemotherapie plus Nivolumab beim nichtkleinzelligen Lungenkarzinom (NSCLC) in den Stadien II-IIIB Studie Risikogruppe N1 Therapie pCR2 EFÜ4 CheckMate 77T NSCLC, Stadium II-IIIB 461 Platinbasierte Chemotherapie 4,7 18,4 Platinbasierte Chemotherapie + Nivolumab 25,3 n. e. 5 HR3 0,47 p = 0,0025 1N Anzahl Pat., 2pCR pathologische Komplettremission, Rate in %, 3HR Hazard Ratio, 4EFÜ ereignisfreie Überlebenszeit, Median in Monaten, 5n. e. Median nicht erreicht Zusammenfassung der Präsentation Die perioperative Therapie in Kombination einer platinhaltigen Chemotherapie mit Nivolumab, gefolgt von adjuvanter Therapie mit Nivolumab, kann der neue Standard bei Pat. mit resektablen NSCLC werden.
Adding modified FOLFOX6 (folinic acid, fluorouracil, and oxaliplatin) after chemoradiotherapy and lengthening the chemoradiotherapy-to-surgery interval is associated with an increase in the ...proportion of rectal cancer patients with a pathological complete response.
The purpose of this study was to analyze disease-free and overall survival.
This was a nonrandomized phase II trial.
The study was conducted at multiple institutions.
Four sequential study groups with stage II or III rectal cancer were included.
All of the patients received 50 Gy of radiation with concurrent continuous infusion of fluorouracil for 5 weeks. Patients in each group received 0, 2, 4, or 6 cycles of modified FOLFOX6 after chemoradiation and before total mesorectal excision. Patients were recommended to receive adjuvant chemotherapy after surgery to complete a total of 8 cycles of modified FOLFOX6.
The trial was powered to detect differences in pathological complete response, which was reported previously. Disease-free and overall survival are the main outcomes for the current study.
Of 259 patients, 211 had a complete follow-up. Median follow-up was 59 months (range, 9-125 mo). The mean number of total chemotherapy cycles differed among the 4 groups (p = 0.002), because one third of patients in the group assigned to no preoperative FOLFOX did not receive any adjuvant chemotherapy. Disease-free survival was significantly associated with study group, ypTNM stage, and pathological complete response (p = 0.004, <0.001, and 0.001). A secondary analysis including only patients who received ≥1 cycle of FOLFOX still showed differences in survival between study groups (p = 0.03).
The trial was not randomized and was not powered to show differences in survival. Survival data were not available for 19% of the patients.
Adding modified FOLFOX6 after chemoradiotherapy and before total mesorectal excision increases compliance with systemic chemotherapy and disease-free survival in patients with locally advanced rectal cancer. Neoadjuvant consolidation chemotherapy may have benefits beyond increasing pathological complete response rates. See Video Abstract at http://links.lww.com/DCR/A739.
This is a protocol for a Cochrane Review (intervention). The objectives are as follows:
To assess the effects of platinum‐based chemotherapy as adjuvant and neoadjuvant treatment for patients with ...early triple negative breast cancer
Systemic failure remains the major challenge in management of locally advanced rectal cancer (LARC). To optimize the timing of neoadjuvant treatment and enhance systemic control, we initiated a phase ...2 trial to evaluate a new strategy of neoadjuvant sandwich treatment, integrating induction chemotherapy, concurrent chemoradiation therapy, and consolidation chemotherapy. Here, we present preliminary results of this trial, reporting the tumor response, toxicities, and surgical complications.
Fifty-one patients with LARC were enrolled, among which were two patients who were ineligible because of distant metastases before treatment. Patients were treated first with one cycle of induction chemotherapy consisting of oxaliplatin, 130 mg/m² on day 1, with capecitabine, 1000 mg/m² twice daily for 14 days every 3 weeks (the XELOX regimen), followed by chemoradiation therapy, 50 Gy over 5 weeks, with the modified XELOX regimen (oxaliplatin 100 mg/m²), and then with another cycle of consolidation chemotherapy with the XELOX regimen. Surgery was performed 6 to 8 weeks after completion of radiation therapy. Tumor responses, toxicities, and surgical complications were recorded.
All but one patent completed the planned schedule of neoadjuvant sandwich treatment. Neither life-threatening blood count decrease nor febrile neutropenia were observed. Forty-five patents underwent optimal surgery with total mesorectal excision (TME). Four patients refused surgery because of clinically complete response. There was no perioperative mortality in this cohort. Five patients (11.1%) developed postoperative complications. Among the 45 patients who underwent TME, pathologic complete response (pCR), pCR or major regression, and at least moderate regression were achieved in 19 (42.2%), 37 (82.2%), and 44 patients (97.8%), respectively.
Preliminary results suggest that the strategy of neoadjuvant sandwich treatment using XELOX regimen as induction, concomitant, and consolidation chemotherapy to the conventional radiation is well tolerated. The strategy is highly effective in terms of pCR and major regression, which warrants further investigation.
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