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HD-MT With/Without IT-MT and WBRT for Primary CNS Lymphoma

KEY TAKEAWAYS The study aimed to evaluate the efficacy and safety of HD-MT with or without IT-MT and WBRT for PCNSL. The results showed no significant difference in efficacy between HD-MT alone or with IT-MT plus radiotherapy, with manageable side effects. Primary...

Sep 19, 2024

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Proapoptotic Potential of MAC-NCs in Gastric Cancer Cells

KEY TAKEAWAYS

  • The study aimed to integrate MAC-NCs to improve pro-apoptotic effects on AGS gastric cancer cells.
  • The synthesised MAC-NCs showed potential as a selective anti-gastric cancer agent, however, more in vivo studies are needed to confirm these findings.

Gastric cancer is a significant health concern, and the search for effective treatments is ongoing. Myricetin, a natural flavanol, has shown potential in inhibiting cancer cell growth and promoting cell death. However, its low bioavailability and short lifespan in the body have limited its therapeutic application.

Mahdieh Teimouri and the team aimed to investigate if encapsulating myricetin in alginate-cellulose hybrid nanocrystals (MAC-NCs) could enhance its delivery and anti-cancer effects on human AGS gastric cancer cells.

The study involved synthesizing and characterizing MAC-NCs using techniques such as Dynamic Light Scattering (DLS), Fourier Transform Infrared Spectroscopy (FTIR), Field Emission Scanning Electron Microscope (FESEM), and Zeta-potential analyses.

The cytotoxic activity of these nanoparticles was then assessed on both cancerous (AGS) and normal (Huvec) cells. The study also examined the expression of apoptotic markers, Caspase 8 and Caspase 9, and confirmed cell death type using DAPI staining and flow cytometry on AGS cells.

The results showed that the synthesized MAC-NCs, with a size of 40 nm, exhibited significant selective toxicity towards human gastric cells (IC50 of 31.05 µg/mL) compared to normal endothelial cells (IC50 of 214.26 µg/mL).

Further analysis using DAPI and annexin flow cytometry confirmed the induction of apoptosis in gastric cells. Interestingly, this apoptosis was found to be independent of Caspase-8 and Caspase-9 activity.

The findings suggested that MAC-NCs hold promise as a targeted therapeutic approach for gastric cancer treatment. The selective toxicity towards cancer cells while sparing normal cells highlights its potential advantages.

However, further in vivo studies are necessary to validate these findings and to comprehensively evaluate its safety and efficacy as a pharmaceutical agent.

This research was conducted at a personal expense in the laboratory at the Islamic Azad University of Mashhad.

Source: https://pubmed.ncbi.nlm.nih.gov/39299971/

Teimouri M, Homayouni Tabrizi M, Karimi E. (2024). “The selective proapoptotic impact of the myricetin-loaded alginate-cellulose hybrid nanocrystals (MAC-NCs) on the human AGS gastric cancer cells.” Mol Biol Rep. 2024;51(1):998. Published 2024 Sep 19. doi:10.1007/s11033-024-09864-0

Impact of High-Dose Vitamin D on mCRC With Chemo+Bev

KEY TAKEAWAYS

  • The SOLARIS phase 3 trial investigated the effect of high-dose vitamin D3 on PFS in patients with mCRC.
  • Researchers found that high-dose vitamin D3 showed no overall benefit for PFS but may help patients with mCRC.

Higher 25-hydroxyvitamin D levels have been linked to improved colorectal cancer (CRC) survival. The SUNSHINE phase II randomized controlled trial (RCT) demonstrated that patients with metastatic CRC (mCRC) receiving first-line (1L) chemotherapy plus bevacizumab and high-dose vitamin D3 had better progression-free survival (PFS) compared to those on standard-dose vitamin D3. The SOLARIS trial was designed to further evaluate the efficacy of high-dose vitamin D in mCRC.

Fei Ma and the team aimed to assess the impact of high-dose vitamin D3 combined with standard chemotherapy and bevacizumab on PFS in patients with previously untreated mCRC.

They performed an inclusive analysis in the double-blind phase III RCT, SOLARIS, involving patients with mCRC who had not received prior therapy, had an ECOG performance status of 0-1, and were not taking vitamin D ≥2,000 IU/d. Patients were randomized 1:1 to receive either high-dose vitamin D3 (8,000 IU/d for 14 days, then 4,000 IU/d) or standard-dose vitamin D3 (400 IU/d), in addition to mFOLFOX6 or FOLFIRI plus bevacizumab.

Stratification factors included chemotherapy backbone, performance status, and tumor sidedness. Treatment continued until disease progression, unacceptable toxicity, or withdrawal of consent. The primary intent-to-treat analysis compared PFS between the 2 arms using an unstratified log-rank test. Hazard ratios (HR) with 95% confidence intervals (CI) were derived from a Cox model, and median PFS was estimated using the Kaplan-Meier method.

With 273 PFS events from 450 patients and 1 interim analysis for futility, the study had 90% power to detect an HR of 0.70 (median PFS of 10 vs. 14.3 months) using a one-sided log-rank test with α=0.05. Secondary endpoints included response rate, overall survival (OS), and toxicity.

About 455 patients were randomized between October 2019 and December 2022. The median age was 59 years (range 27-92), with 60% male and 52% having a performance status of 0; 64% had a left-sided primary tumor. The median follow-up for PFS was 20 months (Q1, Q3: 7, 35 months), with 286 events. High-dose vitamin D3 did not improve PFS compared to standard-dose vitamin D3 (median PFS 11.8 vs. 10.3 months; HR 0.92, 95% CI 0.73-1.16; log-rank P=0.25).

Response rates were 51% vs. 44% (P=0.12), and median OS was 25.6 vs. 27.0 months (HR 1.05, 95% CI 0.81-1.36; log-rank P=0.34). Pre-planned subgroup analyses revealed a PFS benefit in patients with left-sided mCRC treated with high-dose versus standard-dose vitamin D3 (HR 0.74, 95% CI 0.55-1.00; P interaction=0.02). The most common grade ≥3 toxicities, including neutropenia/leukopenia, hypertension, peripheral neuropathy, and diarrhea, were not significantly different between the arms.

The study concluded that the addition of high-dose vitamin D3 to standard treatment did not improve PFS compared to standard-dose vitamin D3 in patients with mCRC. However, a potential benefit was observed in patients with left-sided mCRC.

The trial was sponsored by the Alliance for Clinical Trials in Oncology.

Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/129

Clinical Trial: https://clinicaltrials.gov/study/NCT04094688

Ng K, Ou F.S, Zemla T, et al. (2024). “SOLARIS (Alliance A021703): A multicenter double-blind phase III randomized clinical trial (RCT) of vitamin D (VitD) combined with standard chemotherapy plus bevacizumab (bev) in patients (pts) with previously untreated metastatic colorectal cancer (mCRC).” Presented at ESMO 2024 (Abstract LBA26).

Efficacy of Axitinib + Avelumab in Pretreated Advanced GIST

KEY TAKEAWAYS

  • The AXAGIST phase 2 trial aimed to investigate the synergy of axitinib and avelumab in advanced GIST after standard therapy failure.
  • The primary endpoint was to determine PFS.
  • Researchers noted significant efficacy and long-term benefit from the axitinib-avelumab combination in pretreated GIST.

The development of tyrosine kinase inhibitors (TKIs) has significantly advanced the treatment of unresectable or metastatic gastrointestinal stromal tumors (GISTs), yet resistance mechanisms continue to drive disease progression.

Piotr Rutkowski and the team considered the potential immunomodulatory effects of VEGF inhibitors and hypothesized that combining VEGF and PD-L1 inhibitors could have a synergistic effect and improve therapeutic outcomes.

They performed an inclusive analysis of AXAGIST (NCT04258956), a 2-centre, single-arm, phase II, 2-stage trial evaluating the efficacy and safety of avelumab (10 mg/kg IV Q2W) combined with axitinib (5 mg PO BID) in patients with unresectable or metastatic GIST after the failure of standard therapy. The primary endpoint was progression-free survival (PFS) at 3 months according to RECIST 1.1 criteria. Secondary endpoints included overall survival (OS), overall response rate (ORR), and safety.

About 58 patients were enrolled, with 56 evaluable for safety and efficacy. The median age was 60 years (range 18-80); 21 patients (37.5%) were female, and 30 patients (53.6%) had received prior treatment with 3 lines of TKIs. The median follow-up was 27.4 months (95% CI, 25.4-NA). The best response included partial response in 5 patients (8.9%), stable disease in 34 patients (60.7%), and progressive disease in 17 patients (30.4%).

Among patients with partial response, the median duration of response was 18.5 months (95% CI, 18.3-NA). The PFS rate at 3 months was 57.1%. Median PFS and OS were 4.6 months (95% CI, 2.9-6.4) and 14.2 months (95% CI, 9.2-26.3), respectively.

The 12-month PFS and OS rates were 22.8% (95% CI: 14-37.1) and 59.3% (95% CI: 47.5-74), respectively. Adverse events (AEs) occurred in 94.6% of patients, with 30.4% experiencing grade 3 or higher AEs, all of which were manageable.

The study concluded that the combination of targeted therapy and immunotherapy demonstrated significant efficacy in pretreated patients with GIST. A substantial subset of patients achieved long-term clinical benefit, with further biomarker correlations to be presented.

The trial was sponsored by Maria Sklodowska-Curie National Research Institute of Oncology.

Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/47

Clinical Trial: https://clinicaltrials.gov/study/NCT04258956

Rutkowski P, Klimczak A, Teterycz P, et al. (2024). “Axitinib plus avelumab in patients with unresectable/metastatic gastrointestinal stromal tumor (GIST) after failure of standard therapy: Single-arm phase II study (AXAGIST).” Presented at ESMO 2024 (Abstract 1723MO).

Periop Chemo Alone vs Preop CRT in Resectable Gastric Cancer

Periop Chemo Alone vs Preop CRT in Resectable Gastric Cancer

KEY TAKEAWAYS

  • The TOPGEAR phase II & III trial aimed to assess if adding preop CRT to periop CT improves outcomes in resectable gastric cancer.
  • The primary endpoint was to determine OS.
  • The preop CRT improves pathological outcomes but does not enhance OS compared to periop CT alone.

In Western countries, resectable gastric cancer is usually treated with perioperative chemotherapy (periop CT). There is interest in adding preoperative chemoradiotherapy (preop CRT), but it has not been compared to perioperative CT alone.

Trevor Leong and the team aimed to verify if adding preop CRT to periop CT improves pathological complete response (pCR) and overall survival (OS) compared to perioperative CT alone.

The TOPGEAR phase 3 trial randomly assigned patients with resectable stomach and gastro-esophageal junction adenocarcinoma to receive either periop CT or with preop CRT. The CT-only group received either 3 cycles of epirubicin/cisplatin/5-fluorouracil (ECF) or 4 cycles of fluorouracil/leucovorin/oxaliplatin/docetaxel (FLOT) before and after surgery.

The preop CRT group received 1 less cycle of preop chemotherapy, followed by CRT (45 Gy radiation plus infusional 5-FU) and then the same postoperative CT. The primary endpoint was OS, whereas pFS, pCR rates, toxicity, and quality of life were secondary goals.

The results showed that between September 2009 and May 2021, 574 patients from 70 sites across Australasia, Europe, and Canada were enrolled. Of all the patients, 288 were randomized to the perioperative CT group, and 286 were randomized to the preoperative CRT group.

The patients receiving preoperative CRT had a higher pCR rate (16.7% vs. 8.0%), a better major pathological response rate (49.5% vs. 29.3%), and more tumor downstaging. After a median follow-up of 66.7 months, OS and pFS were similar.

The median OS was 49.4 months for periop CT vs. 46.4 months for preop CRT, and the median PFS was 31.8 months for periop CT vs. 31.4 months for preop CRT. Preop CRT did not lead to more treatment toxicity or surgical complications.

The study concluded that while preoperative CRT improves pathological outcomes, it does not enhance OS compared to periop CT alone in patients with resectable gastric and gastro-esophageal junction adenocarcinoma.

The trial was sponsored by Australasian Gastro-Intestinal Trials Group.

Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/43

Clinical Trial: https://clinicaltrials.gov/study/NCT01924819

Leong T, Smithers BM, Michael M, et al. (2024). “A randomized phase III trial of perioperative chemotherapy (periop CT) with or without preoperative chemoradiotherapy (preop CRT) for resectable gastric cancer (AGITG TOPGEAR): Final results from an intergroup trial of AGITG, TROG, EORTC and CCTG.” Presented at ESMO 2024 (Abstract LBA58).

Efficacy of Ramucirumab Plus TAS102 in Heavily Treated mCRC

KEY TAKEAWAYS

  • The study aimed to investigate the impact of adding ramucirumab to trifluridin/tipiracil in heavily pretreated mCRC.
  • The primary endpoint was to determine OS and the secondary endpoints were DCR, PFS and safety.
  • Researchers noted that ramucirumab improved survival in select heavily pretreated patients with mCRC, indicating the need for personalized treatment.

Patients with chemotherapy-refractory metastatic colorectal cancer (mCRC) face limited treatment options. Trifluridin/tipiracil (FTD/TPI) is a standard therapy for those who have progressed through 2 lines of combination treatments. Antiangiogenic agents are known to be effective in combination with other therapies for mCRC.

Stefan Kasper-Virchow and the team conducted a randomized phase III trial to evaluate the efficacy and safety of FTD/TPI with or without ramucirumab (ram) in patients with heavily pretreated mCRC.

They performed an inclusive analysis of patients with mCRC who had been previously treated with oxaliplatin, irinotecan, fluoropyrimidine, anti-EGFR antibodies (when indicated), and anti-angiogenics. These patients were randomized 1:1 to receive either trifluridin/tipiracil (35 mg/m² on days 1-5 and 8-12, every 4 weeks) with ram (8 mg/kg on days 1 and 15, every 4 weeks) (Arm A) or trifluridin/tipiracil alone (Arm B). The primary endpoint was overall survival (OS), while secondary endpoints included disease control rate (DCR), progression-free survival (PFS), and safety.

About 428 patients (213 in arm A and 215 in arm B) were enrolled at 43 centers in Germany from December 2018 to January 2023. The median age was 62 (range 25-90); 45.1% were female; 61.7% had RAS mutations, and 67.1% had left-sided tumors. A total of 62.6% of patients had received more than two prior treatments for mCRC.

In arm A, there were more treatment-related adverse events (TRAEs) of grade ≥3 (55.9% vs 36.8%; mainly hypertension and neutropenia) and more dose reductions of FTD/TPI (40.8% vs 24.2%). No new safety signals emerged.

The median overall survival (OS) was 7.46 months for arm A versus 7.06 months for arm B (HR 0.871; P=0.1941), indicating that the primary endpoint was not met. Median PFS was 2.37 months in arm A versus 2.07 months in arm B (HR 0.774; P=0.011). The DCR was higher in the ram/FTD-TPI arm (39.4% vs. 31.6%; P=0.0336). Interestingly, OS was improved with ram combination therapy in female patients (HR 0.712; P=0.0371) and those with left-sided tumors (HR 0.770; P=0.0469).

The study concluded that while the RAMTAS trial did not meet its primary endpoint of OS in the intention-to-treat population, adding ram to trifluridin/tipiracil selectively improved survival in heavily pretreated female patients and those with left-sided mCRC. These findings support the personalization of treatment decisions in patients with mCRC who have failed multiple lines of standard therapy.

The trial was sponsored by the Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest.

Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/129

Clinical Trial: https://clinicaltrials.gov/study/NCT03520946

Hofheinz R.D, Virchow S.K, Stintzing S, et al. (2024). “Randomized phase III trial of ramucirumab in combination with TAS102 (Trifluridin/Tipiracil) vs. TAS102 monotherapy in heavily pretreated metastatic colorectal cancer: The RAMTAS/IKF643 trial of the German AIO (AIO-KRK-0316).” Presented at ESMO 2024 (Abstract LBA25).

Prospective Evidence of Adjuvant Aspirin in PIK3CA Colon Cancer

KEY TAKEAWAYS

  • The SAKK 41/13 phase III trial verified the benefits of adjuvant aspirin for patients with PIK3CA-mutant colon cancer.
  • The primary endpoint was to determine DFS and the secondary endpoints were OS & AEs.
  • Aspirin showed a 43% DFS improvement in PIK3CA-mutant colon cancer.

Several retrospective studies suggest a potential protective effect of aspirin as an adjuvant therapy for colon cancer, especially in patients with an activating PIK3CA mutation.

Ulrich Güller and the team aimed to confirm the benefit of adjuvant aspirin in patients with PIK3CA-mutated colon cancer.

This phase III, randomized, placebo-controlled, double-blind trial included stage II and III patients with colon cancer with a centrally assessed PIK3CA mutation in Exon 9 or 20. Patients were randomized 2:1 to receive either 100mg of aspirin daily or placebo for 3 years.

The primary endpoint was disease-free survival (DFS), with secondary endpoints were overall survival (OS) and tracking adverse events (AEs). One-sided type I error was 5% with a power of 80% to detect an HR of <0.456. The study was prematurely closed due to financial constrains.

The results showed that 112 patients were included in the trial, with 74 in the aspirin and 38 in the placebo groups. The median age was 66 [IQR: 29-89], and 42.9% were female.

After a median follow-up of 4 years, there were 19 DFS events. Aspirin showed a DFS hazard ratio (HR) of 0.57 (90% CI: 0.27-1.22, P=0.11) with 3-year DFS rates of 88.3% (90% CI: 80.1-93.3) for aspirin and 82.4% (90% CI: 68.3- 90.7) for placebo. The OS HR was 0.70 (90% CI: 0.23-2.12, P=0.3). No severe aspirin-related AEs were reported.

The study concluded that the SAKK 41/13 trial offers the first prospective evidence of adjuvant aspirin’s protective effect in resected, PIK3CA-mutant colon cancer, showing a 43% improvement in DFS, though statistical significance was limited by sample size.

The trial was sponsored by the Swiss Group for Clinical Research.

Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/116

Clinical Trial: https://clinicaltrials.gov/study/NCT02467582

Güller U, Hayoz S, Horber D, et al. (2024). “Adjuvant aspirin treatment in PIK3CA mutated colon cancer patients: The phase III, prospective-randomized placebo-controlled multicenter SAKK 41/13 trial.” Presented at ESMO 2024 (Abstract 512O).

LBM Dosing Reduces Ox-Induced Neurotoxicity in CRC

KEY TAKEAWAYS

  • The LEANOX phase II trial aimed to determine if LBM-based Ox dosing reduces OIPN.
  • The primary endpoint was to determine OIPN.
  • Lean-body mass-based dosing significantly reduced OIPN without affecting RFS or OS.

FOLFOX or CAPOX-based adjuvant chemotherapy is the standard treatment for operable stage III colorectal cancer (CRC), but a significant side effect is neurotoxicity. Previous research identified higher toxicity in patients receiving more than 3.09 mg of oxaliplatin (Ox) per kilogram of lean body mass (LBM).

Eric Assenat and the team aimed to evaluate whether administering Ox-based on LBM could reduce the incidence and severity of Ox-induced peripheral neurotoxicity (OIPN).

The study included patients with CRC eligible for adjuvant Ox chemotherapy. Group 1 received a body surface area (BSA)-based Ox dose (85 mg/m²). Patients with reduced LBM were randomized (1:1) to either a BSA-based Ox dose (Group 2) or an LBM-based dose (3.09 mg/kg LBM) (Group 3).

The primary goal was to assess the percentage of patients without grade ≥2 OIPN during the initial 6 treatment cycles. A total of 108 randomized patients were needed to compare groups 2 and 3, with a 2-sided α of 0.05 and 80% power.

The results showed that among 160 patients (median age: 63, 52.5% male, 89.3% ECOG 0), 33 were in group 1, 64 were in group 2, and 63 were in group 3. The tumor stage was pT3 (57.5%), pT4 (33.8%), pN1 (60.6%), and pN2 (38.1%).

Around 67.2% of patients in group 3 avoided grade ≥2 OIPN during the first 6 cycles, compared to 42.1% in group 2 (P=0.01). Group 3 showed better OIPN-free survival (HR 0.53, [0.34-0.84] P=0.01), longer time to grade ≥2 OIPN (P=0.006), and tolerated a higher cumulative Ox dosage without OIPN (P=0.044) alongside higher Ox dose reductions (P<0.001).

The duration of grade ≥2 OIPN and OIPN-related treatment interruptions was similar between groups (P=0.908). After 38.6 months, both groups had similar relapse-free survival (RFS) (HR 1.05, P=0.88) and OS (HR 1.20, P=0.77). Group 3 showed significantly better neurotoxicity scores.

The study concluded that administering Ox-based treatment using an LBM-based Ox dose in the adjuvant setting significantly reduces OIPN and enhances the quality of life without adversely affecting RFS or OS.

The trial was sponsored by Institut du Cancer de Montpellier – Val d’Aurelle and funded by the French Ministry of Health and the National Institute of Cancer.

Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/116

Clinical Trial: https://clinicaltrials.gov/study/NCT03255434

Assenat E, Abdelghani MB, Gourgou S, et al. (2024). “Impact of lean body mass-based oxaliplatin dosage on neurotoxicity in adjuvant treatment of stage III colorectal cancer: Final results of the phase II randomized multicenter LEANOX trial,” Presented at ESMO 2024 (Abstract 507O)

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