Subcutaneous injection of diclofenac sodium is effective against acute migraine

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Key clinical point: Self-administered single-dose subcutaneous (SC) injection of diclofenac sodium (50 mg/mL) complexed with hydroxypropyl-β-cyclodextrin (HPβCD) is safe and effective for the treatment of acute migraine attacks in patients with moderate-to-severe migraine pain.

Major finding: After 2 hours of injection, 46.7% of patients were pain-free in the 50 mg diclofenac/HPβCD group, with the percentage being significantly higher than that in the placebo group (16.1%; P = .01). Most treatment-emergent adverse events were mild.

Study details: The findings are from a multicenter, phase 2, dose-finding pilot study including 122 adult patients experiencing 2-8 migraine attacks/month with moderate-to-severe pain who were randomly assigned to receive diclofenac/HPβCD (25, 50, or 75 mg) or placebo.

Disclosures: The study was sponsored by IBSA Institut Biochimique S.A. (Switzerland). Some authors declared serving as advisory board members, consultants, or speakers, or receiving honoraria for clinical investigation studies, travel and research grants, or personal fees from various sources.

Source: Geppetti P et al. Self-administered subcutaneous diclofenac sodium in acute migraine attack: A randomized, double-blind, placebo-controlled dose-finding pilot study. Cephalalgia. 2022 (Apr 26). Doi: 10.1177/03331024221093712

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Key clinical point: Self-administered single-dose subcutaneous (SC) injection of diclofenac sodium (50 mg/mL) complexed with hydroxypropyl-β-cyclodextrin (HPβCD) is safe and effective for the treatment of acute migraine attacks in patients with moderate-to-severe migraine pain.

Major finding: After 2 hours of injection, 46.7% of patients were pain-free in the 50 mg diclofenac/HPβCD group, with the percentage being significantly higher than that in the placebo group (16.1%; P = .01). Most treatment-emergent adverse events were mild.

Study details: The findings are from a multicenter, phase 2, dose-finding pilot study including 122 adult patients experiencing 2-8 migraine attacks/month with moderate-to-severe pain who were randomly assigned to receive diclofenac/HPβCD (25, 50, or 75 mg) or placebo.

Disclosures: The study was sponsored by IBSA Institut Biochimique S.A. (Switzerland). Some authors declared serving as advisory board members, consultants, or speakers, or receiving honoraria for clinical investigation studies, travel and research grants, or personal fees from various sources.

Source: Geppetti P et al. Self-administered subcutaneous diclofenac sodium in acute migraine attack: A randomized, double-blind, placebo-controlled dose-finding pilot study. Cephalalgia. 2022 (Apr 26). Doi: 10.1177/03331024221093712

Key clinical point: Self-administered single-dose subcutaneous (SC) injection of diclofenac sodium (50 mg/mL) complexed with hydroxypropyl-β-cyclodextrin (HPβCD) is safe and effective for the treatment of acute migraine attacks in patients with moderate-to-severe migraine pain.

Major finding: After 2 hours of injection, 46.7% of patients were pain-free in the 50 mg diclofenac/HPβCD group, with the percentage being significantly higher than that in the placebo group (16.1%; P = .01). Most treatment-emergent adverse events were mild.

Study details: The findings are from a multicenter, phase 2, dose-finding pilot study including 122 adult patients experiencing 2-8 migraine attacks/month with moderate-to-severe pain who were randomly assigned to receive diclofenac/HPβCD (25, 50, or 75 mg) or placebo.

Disclosures: The study was sponsored by IBSA Institut Biochimique S.A. (Switzerland). Some authors declared serving as advisory board members, consultants, or speakers, or receiving honoraria for clinical investigation studies, travel and research grants, or personal fees from various sources.

Source: Geppetti P et al. Self-administered subcutaneous diclofenac sodium in acute migraine attack: A randomized, double-blind, placebo-controlled dose-finding pilot study. Cephalalgia. 2022 (Apr 26). Doi: 10.1177/03331024221093712

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Migraine: Ubrogepant therapy yields favorable 2-hour outcomes in triptan insufficient responders

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Key clinical point: Compared with placebo, ubrogepant therapy provides favorable 2-hour outcomes, as measured by functional disability, medication satisfaction, and impression of overall change in migraine, in patients with migraine who are triptan insufficient responders (TIR).

Major finding: At 2 hours after initial dose of ubrogepant vs placebo, significantly greater proportion of patients reported no disability (38% vs 29%; odds ratio [OR] 1.5; P = .048), treatment satisfaction (33% vs 21%; OR 1.8; P = .006), and improvement in migraine (30% vs 18%; OR 2.0; P = .006).

Study details: This post hoc analysis included 1799 patients with migraine with or without aura from the phase 3 ACHIEVE I and ACHIEVE II trials who were self-reported TIR and received 50 mg ubrogepant (n = 887) or placebo (n = 912).

Disclosures: The study was funded by Allergan (before acquisition by AbbVie). Some authors declared serving as consultants or advisory board members and receiving research support, honoraria, or royalties from various sources, including AbbVie/Allergan. The other authors are current or former employees and stockholders of AbbVie.

Source: Lipton RB et al. Functionality, satisfaction, and global impression of change with ubrogepant for the acute treatment of migraine in triptan insufficient responders: A post hoc analysis of the ACHIEVE I and ACHIEVE II randomized trials. J Headache Pain. 2022;23:50 (Apr 25). Doi: 10.1186/s10194-022-01419-7

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Key clinical point: Compared with placebo, ubrogepant therapy provides favorable 2-hour outcomes, as measured by functional disability, medication satisfaction, and impression of overall change in migraine, in patients with migraine who are triptan insufficient responders (TIR).

Major finding: At 2 hours after initial dose of ubrogepant vs placebo, significantly greater proportion of patients reported no disability (38% vs 29%; odds ratio [OR] 1.5; P = .048), treatment satisfaction (33% vs 21%; OR 1.8; P = .006), and improvement in migraine (30% vs 18%; OR 2.0; P = .006).

Study details: This post hoc analysis included 1799 patients with migraine with or without aura from the phase 3 ACHIEVE I and ACHIEVE II trials who were self-reported TIR and received 50 mg ubrogepant (n = 887) or placebo (n = 912).

Disclosures: The study was funded by Allergan (before acquisition by AbbVie). Some authors declared serving as consultants or advisory board members and receiving research support, honoraria, or royalties from various sources, including AbbVie/Allergan. The other authors are current or former employees and stockholders of AbbVie.

Source: Lipton RB et al. Functionality, satisfaction, and global impression of change with ubrogepant for the acute treatment of migraine in triptan insufficient responders: A post hoc analysis of the ACHIEVE I and ACHIEVE II randomized trials. J Headache Pain. 2022;23:50 (Apr 25). Doi: 10.1186/s10194-022-01419-7

Key clinical point: Compared with placebo, ubrogepant therapy provides favorable 2-hour outcomes, as measured by functional disability, medication satisfaction, and impression of overall change in migraine, in patients with migraine who are triptan insufficient responders (TIR).

Major finding: At 2 hours after initial dose of ubrogepant vs placebo, significantly greater proportion of patients reported no disability (38% vs 29%; odds ratio [OR] 1.5; P = .048), treatment satisfaction (33% vs 21%; OR 1.8; P = .006), and improvement in migraine (30% vs 18%; OR 2.0; P = .006).

Study details: This post hoc analysis included 1799 patients with migraine with or without aura from the phase 3 ACHIEVE I and ACHIEVE II trials who were self-reported TIR and received 50 mg ubrogepant (n = 887) or placebo (n = 912).

Disclosures: The study was funded by Allergan (before acquisition by AbbVie). Some authors declared serving as consultants or advisory board members and receiving research support, honoraria, or royalties from various sources, including AbbVie/Allergan. The other authors are current or former employees and stockholders of AbbVie.

Source: Lipton RB et al. Functionality, satisfaction, and global impression of change with ubrogepant for the acute treatment of migraine in triptan insufficient responders: A post hoc analysis of the ACHIEVE I and ACHIEVE II randomized trials. J Headache Pain. 2022;23:50 (Apr 25). Doi: 10.1186/s10194-022-01419-7

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Galcanezumab reduces acute headache medication use in treatment-resistant migraine

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Key clinical point: In treatment-resistant episodic or chronic migraine, galcanezumab therapy can help achieve a clinically meaningful reduction in monthly acute headache medication use.

Major finding: Galcanezumab vs. placebo led to a significantly greater least-squares mean reduction in monthly acute headache medication use from 1 to 3 months (4.2 vs 0.8 days; P < .0001). At 6 months, the monthly acute headache medication use was similar between the groups.

Study details: The data come from the phase 3 CONQUER study including 462 patients with treatment-resistant episodic or chronic migraine who were randomly assigned to receive galcanezumab (n = 232) or placebo (n = 230) in the double-blind phase (months 1-3), followed by galcanezumab in the open-label phase (months 4-6).

Disclosures: The study was sponsored by Eli Lilly and Company. Some authors declared being on the advisory board or speakers’ bureau for and receiving consulting fees, speaker fees, honoraria, or travel support from various sources, including Eli Lilly. The other authors are employees or stockholders of Eli Lilly or one of its subsidiaries.

Source: Ambrosini A et al. Changes in acute headache medication use and health care resource utilization: Results from a randomized, double-blind, placebo-controlled clinical trial evaluating galcanezumab in adults with treatment-resistant migraine (CONQUER). J Manag Care Spec Pharm. 2022 (Apr 22). Doi: 10.18553/jmcp.2022.21375

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Key clinical point: In treatment-resistant episodic or chronic migraine, galcanezumab therapy can help achieve a clinically meaningful reduction in monthly acute headache medication use.

Major finding: Galcanezumab vs. placebo led to a significantly greater least-squares mean reduction in monthly acute headache medication use from 1 to 3 months (4.2 vs 0.8 days; P < .0001). At 6 months, the monthly acute headache medication use was similar between the groups.

Study details: The data come from the phase 3 CONQUER study including 462 patients with treatment-resistant episodic or chronic migraine who were randomly assigned to receive galcanezumab (n = 232) or placebo (n = 230) in the double-blind phase (months 1-3), followed by galcanezumab in the open-label phase (months 4-6).

Disclosures: The study was sponsored by Eli Lilly and Company. Some authors declared being on the advisory board or speakers’ bureau for and receiving consulting fees, speaker fees, honoraria, or travel support from various sources, including Eli Lilly. The other authors are employees or stockholders of Eli Lilly or one of its subsidiaries.

Source: Ambrosini A et al. Changes in acute headache medication use and health care resource utilization: Results from a randomized, double-blind, placebo-controlled clinical trial evaluating galcanezumab in adults with treatment-resistant migraine (CONQUER). J Manag Care Spec Pharm. 2022 (Apr 22). Doi: 10.18553/jmcp.2022.21375

Key clinical point: In treatment-resistant episodic or chronic migraine, galcanezumab therapy can help achieve a clinically meaningful reduction in monthly acute headache medication use.

Major finding: Galcanezumab vs. placebo led to a significantly greater least-squares mean reduction in monthly acute headache medication use from 1 to 3 months (4.2 vs 0.8 days; P < .0001). At 6 months, the monthly acute headache medication use was similar between the groups.

Study details: The data come from the phase 3 CONQUER study including 462 patients with treatment-resistant episodic or chronic migraine who were randomly assigned to receive galcanezumab (n = 232) or placebo (n = 230) in the double-blind phase (months 1-3), followed by galcanezumab in the open-label phase (months 4-6).

Disclosures: The study was sponsored by Eli Lilly and Company. Some authors declared being on the advisory board or speakers’ bureau for and receiving consulting fees, speaker fees, honoraria, or travel support from various sources, including Eli Lilly. The other authors are employees or stockholders of Eli Lilly or one of its subsidiaries.

Source: Ambrosini A et al. Changes in acute headache medication use and health care resource utilization: Results from a randomized, double-blind, placebo-controlled clinical trial evaluating galcanezumab in adults with treatment-resistant migraine (CONQUER). J Manag Care Spec Pharm. 2022 (Apr 22). Doi: 10.18553/jmcp.2022.21375

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Migraine: Suboptimal first-dose responders may benefit from a second dose of eptinezumab

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Key clinical point: A second dose of eptinezumab may be beneficial in patients with migraine who exhibit a suboptimal first-dose response.

Major finding: Percent change in monthly migraine days (MMD) over weeks 1-12 (PROMISE-1: odds ratio [OR] 0.97; P = .0001; PROMISE-2: OR 0.94; P < .0001) and change in 6-item Headache Impact Test total score (only PROMISE-2: OR 0.92; P = .027) were observed to be significant first-dose predictors of second-dose response.

Study details: This post hoc analysis included patients with migraine (episodic [n = 416; PROMISE-1] and chronic [n = 479; PROMISE-2]), suboptimal response (<50% reduction from baseline in MMD across weeks 1-12), and patient-reported outcome data at weeks 12 and 24.

Disclosures: The study was sponsored by Lundbeck LLC, USA. Some authors declared serving as consultants, advisory board members, or speakers for and receiving speaker honoraria from various sources, including Lundbeck. The other authors are current orformer employees of H. Lundbeck A/S or its subsidiary/contracted service provider.

Source: Schim JD et al. Likelihood of response with subsequent dosing for patients with migraine and initial suboptimal response with eptinezumab: A post hoc analysis of two placebo-controlled randomized clinical trials. Headache. 2022 (May 6). Doi: 10.1111/head.14302

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Key clinical point: A second dose of eptinezumab may be beneficial in patients with migraine who exhibit a suboptimal first-dose response.

Major finding: Percent change in monthly migraine days (MMD) over weeks 1-12 (PROMISE-1: odds ratio [OR] 0.97; P = .0001; PROMISE-2: OR 0.94; P < .0001) and change in 6-item Headache Impact Test total score (only PROMISE-2: OR 0.92; P = .027) were observed to be significant first-dose predictors of second-dose response.

Study details: This post hoc analysis included patients with migraine (episodic [n = 416; PROMISE-1] and chronic [n = 479; PROMISE-2]), suboptimal response (<50% reduction from baseline in MMD across weeks 1-12), and patient-reported outcome data at weeks 12 and 24.

Disclosures: The study was sponsored by Lundbeck LLC, USA. Some authors declared serving as consultants, advisory board members, or speakers for and receiving speaker honoraria from various sources, including Lundbeck. The other authors are current orformer employees of H. Lundbeck A/S or its subsidiary/contracted service provider.

Source: Schim JD et al. Likelihood of response with subsequent dosing for patients with migraine and initial suboptimal response with eptinezumab: A post hoc analysis of two placebo-controlled randomized clinical trials. Headache. 2022 (May 6). Doi: 10.1111/head.14302

Key clinical point: A second dose of eptinezumab may be beneficial in patients with migraine who exhibit a suboptimal first-dose response.

Major finding: Percent change in monthly migraine days (MMD) over weeks 1-12 (PROMISE-1: odds ratio [OR] 0.97; P = .0001; PROMISE-2: OR 0.94; P < .0001) and change in 6-item Headache Impact Test total score (only PROMISE-2: OR 0.92; P = .027) were observed to be significant first-dose predictors of second-dose response.

Study details: This post hoc analysis included patients with migraine (episodic [n = 416; PROMISE-1] and chronic [n = 479; PROMISE-2]), suboptimal response (<50% reduction from baseline in MMD across weeks 1-12), and patient-reported outcome data at weeks 12 and 24.

Disclosures: The study was sponsored by Lundbeck LLC, USA. Some authors declared serving as consultants, advisory board members, or speakers for and receiving speaker honoraria from various sources, including Lundbeck. The other authors are current orformer employees of H. Lundbeck A/S or its subsidiary/contracted service provider.

Source: Schim JD et al. Likelihood of response with subsequent dosing for patients with migraine and initial suboptimal response with eptinezumab: A post hoc analysis of two placebo-controlled randomized clinical trials. Headache. 2022 (May 6). Doi: 10.1111/head.14302

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Evidence of real-world effectiveness of erenumab against chronic migraine

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Key clinical point: Erenumab is effective in managing patients with treatment-resistant chronic migraine in a tertiary care setting without causing any serious adverse effects.

Major finding: At 3 and 6 months, erenumab significantly reduced the median monthly migraine days (MMD; −4 and −9 days, respectively; P < .001), with the MMD 50% responder rate at 3 months being 36%. No serious adverse events were observed.

Study details: This was a prospective study including 92 patients aged >18 years with chronic migraine and ≥3 prior migraine preventive treatment failures who received monthly 70 mg erenumab for 3 months.

Disclosures: The authors did not report any source of funding or conflict of interests.

Source: Khalil M et al. Erenumab in chronic migraine: Experience from a UK tertiary centre and comparison with other real-world evidence. Eur J Neurol. 2022 (Apr 21). Doi: 10.1111/ene.15364

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Key clinical point: Erenumab is effective in managing patients with treatment-resistant chronic migraine in a tertiary care setting without causing any serious adverse effects.

Major finding: At 3 and 6 months, erenumab significantly reduced the median monthly migraine days (MMD; −4 and −9 days, respectively; P < .001), with the MMD 50% responder rate at 3 months being 36%. No serious adverse events were observed.

Study details: This was a prospective study including 92 patients aged >18 years with chronic migraine and ≥3 prior migraine preventive treatment failures who received monthly 70 mg erenumab for 3 months.

Disclosures: The authors did not report any source of funding or conflict of interests.

Source: Khalil M et al. Erenumab in chronic migraine: Experience from a UK tertiary centre and comparison with other real-world evidence. Eur J Neurol. 2022 (Apr 21). Doi: 10.1111/ene.15364

Key clinical point: Erenumab is effective in managing patients with treatment-resistant chronic migraine in a tertiary care setting without causing any serious adverse effects.

Major finding: At 3 and 6 months, erenumab significantly reduced the median monthly migraine days (MMD; −4 and −9 days, respectively; P < .001), with the MMD 50% responder rate at 3 months being 36%. No serious adverse events were observed.

Study details: This was a prospective study including 92 patients aged >18 years with chronic migraine and ≥3 prior migraine preventive treatment failures who received monthly 70 mg erenumab for 3 months.

Disclosures: The authors did not report any source of funding or conflict of interests.

Source: Khalil M et al. Erenumab in chronic migraine: Experience from a UK tertiary centre and comparison with other real-world evidence. Eur J Neurol. 2022 (Apr 21). Doi: 10.1111/ene.15364

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Fremanezumab can prevent migraine across a broad real-world patient population

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Key clinical point: Fremanezumab treatment leads to clinically meaningful improvement in patients with migraine for up to 6 months, regardless of the dosing regimen or number of prior migraine preventive treatment failures.

Major finding: At 6 months, mean percentage reductions from baseline in monthly migraine days, monthly headache days, Migraine Disability Assessment score, and 6-item Headache Impact Test score were 72.4% (−9.2 days), 70.0% (−9.8 days), 63.1% (−18.1 days), and 27.0% (−16.2 days), respectively. Subgroups formed according to the dosing schedule and number of prior migraine preventive treatment failures showed similar improvements.

Study details: This was a retrospective, online physician chart review study that included data from 421 clinicians and 1003 patients with migraine who had initiated fremanezumab treatment at ≥18 years of age and received ≥1 fremanezumab dose.

Disclosures: The study was sponsored by Teva Pharmaceuticals. Some authors declared being current or former employees of Teva. The other authors are employees of an organization funded by Teva.

Source: Driessen MT et al. Real-world effectiveness of fremanezumab in migraine patients initiating treatment in the United States: results from a retrospective chart study. J Headache Pain. 2022;23:47 (Apr 11). Doi: 10.1186/s10194-022-01411-1

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Key clinical point: Fremanezumab treatment leads to clinically meaningful improvement in patients with migraine for up to 6 months, regardless of the dosing regimen or number of prior migraine preventive treatment failures.

Major finding: At 6 months, mean percentage reductions from baseline in monthly migraine days, monthly headache days, Migraine Disability Assessment score, and 6-item Headache Impact Test score were 72.4% (−9.2 days), 70.0% (−9.8 days), 63.1% (−18.1 days), and 27.0% (−16.2 days), respectively. Subgroups formed according to the dosing schedule and number of prior migraine preventive treatment failures showed similar improvements.

Study details: This was a retrospective, online physician chart review study that included data from 421 clinicians and 1003 patients with migraine who had initiated fremanezumab treatment at ≥18 years of age and received ≥1 fremanezumab dose.

Disclosures: The study was sponsored by Teva Pharmaceuticals. Some authors declared being current or former employees of Teva. The other authors are employees of an organization funded by Teva.

Source: Driessen MT et al. Real-world effectiveness of fremanezumab in migraine patients initiating treatment in the United States: results from a retrospective chart study. J Headache Pain. 2022;23:47 (Apr 11). Doi: 10.1186/s10194-022-01411-1

Key clinical point: Fremanezumab treatment leads to clinically meaningful improvement in patients with migraine for up to 6 months, regardless of the dosing regimen or number of prior migraine preventive treatment failures.

Major finding: At 6 months, mean percentage reductions from baseline in monthly migraine days, monthly headache days, Migraine Disability Assessment score, and 6-item Headache Impact Test score were 72.4% (−9.2 days), 70.0% (−9.8 days), 63.1% (−18.1 days), and 27.0% (−16.2 days), respectively. Subgroups formed according to the dosing schedule and number of prior migraine preventive treatment failures showed similar improvements.

Study details: This was a retrospective, online physician chart review study that included data from 421 clinicians and 1003 patients with migraine who had initiated fremanezumab treatment at ≥18 years of age and received ≥1 fremanezumab dose.

Disclosures: The study was sponsored by Teva Pharmaceuticals. Some authors declared being current or former employees of Teva. The other authors are employees of an organization funded by Teva.

Source: Driessen MT et al. Real-world effectiveness of fremanezumab in migraine patients initiating treatment in the United States: results from a retrospective chart study. J Headache Pain. 2022;23:47 (Apr 11). Doi: 10.1186/s10194-022-01411-1

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Radical surgery improves survival in older patients with gastric cancer

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Key clinical point: Gastrectomy significantly improves survival in older patients with resectable gastric cancer. Renal disease is an independent risk predictor for poorer survival in patients who undergo surgery.

Major finding: In propensity-matched analysis (n = 44), the 3-year overall survival (OS) was significantly longer in the radical surgery vs conservative therapy group (59.4% vs 15.9%, P < .01). No surgery was independently associated with worse OS in the entire cohort (hazard ratio [HR] 3.70; P = .0001). In the surgery group, renal disease was an independent risk factor for poorer OS (HR 2.51; P < .05).

Study details: This was a retrospective observational study of patients aged ≥75 years with clinically resectable primary gastric cancer who underwent radical surgery (n = 115) or received conservative therapy (n = 33).

Disclosures: No funding source was identified for this study. The authors declared no competing interests.

Source: Ito S et al. Survival benefits of gastrectomy compared to conservative observation for older patients with resectable gastric cancer: A propensity score matched analysis. Langenbecks Arch Surg. 2022 (Apr 29). Doi: 10.1007/s00423-022-02511-x

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Key clinical point: Gastrectomy significantly improves survival in older patients with resectable gastric cancer. Renal disease is an independent risk predictor for poorer survival in patients who undergo surgery.

Major finding: In propensity-matched analysis (n = 44), the 3-year overall survival (OS) was significantly longer in the radical surgery vs conservative therapy group (59.4% vs 15.9%, P < .01). No surgery was independently associated with worse OS in the entire cohort (hazard ratio [HR] 3.70; P = .0001). In the surgery group, renal disease was an independent risk factor for poorer OS (HR 2.51; P < .05).

Study details: This was a retrospective observational study of patients aged ≥75 years with clinically resectable primary gastric cancer who underwent radical surgery (n = 115) or received conservative therapy (n = 33).

Disclosures: No funding source was identified for this study. The authors declared no competing interests.

Source: Ito S et al. Survival benefits of gastrectomy compared to conservative observation for older patients with resectable gastric cancer: A propensity score matched analysis. Langenbecks Arch Surg. 2022 (Apr 29). Doi: 10.1007/s00423-022-02511-x

Key clinical point: Gastrectomy significantly improves survival in older patients with resectable gastric cancer. Renal disease is an independent risk predictor for poorer survival in patients who undergo surgery.

Major finding: In propensity-matched analysis (n = 44), the 3-year overall survival (OS) was significantly longer in the radical surgery vs conservative therapy group (59.4% vs 15.9%, P < .01). No surgery was independently associated with worse OS in the entire cohort (hazard ratio [HR] 3.70; P = .0001). In the surgery group, renal disease was an independent risk factor for poorer OS (HR 2.51; P < .05).

Study details: This was a retrospective observational study of patients aged ≥75 years with clinically resectable primary gastric cancer who underwent radical surgery (n = 115) or received conservative therapy (n = 33).

Disclosures: No funding source was identified for this study. The authors declared no competing interests.

Source: Ito S et al. Survival benefits of gastrectomy compared to conservative observation for older patients with resectable gastric cancer: A propensity score matched analysis. Langenbecks Arch Surg. 2022 (Apr 29). Doi: 10.1007/s00423-022-02511-x

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Gastric cancer: Apatinib and PD-1 inhibitors show response in real world study

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Key clinical point: Apatinib plus programmed cell death protein 1 (PD-1) inhibitors show promising response and acceptable tolerance in previously treated real-world patients with advanced gastric cancer.

Major finding: The median follow-up duration was 7.3 months. The objective response rate was 20.5% and disease control rate was 69.2%. The median progression-free survival (PFS) was 3.9 months (95% CI 2.74-5.06), and the median overall survival (OS) was 7.8 (95% CI 4.82-10.78) months. The most common adverse events were fatigue (61.5%), nausea and vomiting (56.4%), diarrhea (48.7%), hypertension (46.2%), hand-foot syndrome (38.5%), and rash (28.2%).

Study details: This was a real-world study of 39 previously treated patients with advanced gastric cancer who received apatinib plus PD-1 blockade treatment between August 2018 and October 2021.

Disclosures: This study was supported by the Natural Science Foundation of Henan Province, China. The authors declared no conflicts of interest.

Source: Li LH et al. Feasibility and tolerance of apatinib plus PD-1 Inhibitors for previously treated;advanced gastric cancer: A real-world exploratory study. Dis Markers. 2022; 4322404 (Apr 29). Doi: 10.1155/2022/4322404

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Key clinical point: Apatinib plus programmed cell death protein 1 (PD-1) inhibitors show promising response and acceptable tolerance in previously treated real-world patients with advanced gastric cancer.

Major finding: The median follow-up duration was 7.3 months. The objective response rate was 20.5% and disease control rate was 69.2%. The median progression-free survival (PFS) was 3.9 months (95% CI 2.74-5.06), and the median overall survival (OS) was 7.8 (95% CI 4.82-10.78) months. The most common adverse events were fatigue (61.5%), nausea and vomiting (56.4%), diarrhea (48.7%), hypertension (46.2%), hand-foot syndrome (38.5%), and rash (28.2%).

Study details: This was a real-world study of 39 previously treated patients with advanced gastric cancer who received apatinib plus PD-1 blockade treatment between August 2018 and October 2021.

Disclosures: This study was supported by the Natural Science Foundation of Henan Province, China. The authors declared no conflicts of interest.

Source: Li LH et al. Feasibility and tolerance of apatinib plus PD-1 Inhibitors for previously treated;advanced gastric cancer: A real-world exploratory study. Dis Markers. 2022; 4322404 (Apr 29). Doi: 10.1155/2022/4322404

Key clinical point: Apatinib plus programmed cell death protein 1 (PD-1) inhibitors show promising response and acceptable tolerance in previously treated real-world patients with advanced gastric cancer.

Major finding: The median follow-up duration was 7.3 months. The objective response rate was 20.5% and disease control rate was 69.2%. The median progression-free survival (PFS) was 3.9 months (95% CI 2.74-5.06), and the median overall survival (OS) was 7.8 (95% CI 4.82-10.78) months. The most common adverse events were fatigue (61.5%), nausea and vomiting (56.4%), diarrhea (48.7%), hypertension (46.2%), hand-foot syndrome (38.5%), and rash (28.2%).

Study details: This was a real-world study of 39 previously treated patients with advanced gastric cancer who received apatinib plus PD-1 blockade treatment between August 2018 and October 2021.

Disclosures: This study was supported by the Natural Science Foundation of Henan Province, China. The authors declared no conflicts of interest.

Source: Li LH et al. Feasibility and tolerance of apatinib plus PD-1 Inhibitors for previously treated;advanced gastric cancer: A real-world exploratory study. Dis Markers. 2022; 4322404 (Apr 29). Doi: 10.1155/2022/4322404

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Gastric cancer: Trastuzumab does not benefit rescued HER2-positive patients

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Key clinical point: Firstline trastuzumab-based chemotherapy shows poorer survival in patients with rescued vs initially human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer.

Major finding: The median follow-up duration was 47.6 months. Rescued HER2-positive patients had a higher rate of immunohistochemistry (IHC) score 2+/in situ hybridization-positive (ISH+; 37.0%) tumors. The median progression-free survival (PFS; 5.7 vs 8.4 months; P = .034) and overall survival (OS; 11.3 vs 16.7 months; P = .02) were significantly shorter in IHC 2+/ISH+ vs IHC 3+ patients. Rescued vs initially HER2-positive patients had worse PFS (5.4 vs 7.8 months; P = .017) and OS (10.4 vs 16.3 months; P = .036).

Study details: A retrospective analysis of 153 patients with HER2-positive advanced gastric cancer who received first-line trastuzumab-based chemotherapy.

Disclosures: No funding source was identified for this work. The authors received consulting fees and honoraria. JH Cheon was the founder and shareholder of Novomics.

Source: Bang K et al. Association between HER2 heterogeneity and clinical outcomes of HER2-positive gastric cancer patients treated with trastuzumab. Gastric Cancer. 2022 (May 7). Doi: 10.1007/s10120-022-01298-6

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Key clinical point: Firstline trastuzumab-based chemotherapy shows poorer survival in patients with rescued vs initially human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer.

Major finding: The median follow-up duration was 47.6 months. Rescued HER2-positive patients had a higher rate of immunohistochemistry (IHC) score 2+/in situ hybridization-positive (ISH+; 37.0%) tumors. The median progression-free survival (PFS; 5.7 vs 8.4 months; P = .034) and overall survival (OS; 11.3 vs 16.7 months; P = .02) were significantly shorter in IHC 2+/ISH+ vs IHC 3+ patients. Rescued vs initially HER2-positive patients had worse PFS (5.4 vs 7.8 months; P = .017) and OS (10.4 vs 16.3 months; P = .036).

Study details: A retrospective analysis of 153 patients with HER2-positive advanced gastric cancer who received first-line trastuzumab-based chemotherapy.

Disclosures: No funding source was identified for this work. The authors received consulting fees and honoraria. JH Cheon was the founder and shareholder of Novomics.

Source: Bang K et al. Association between HER2 heterogeneity and clinical outcomes of HER2-positive gastric cancer patients treated with trastuzumab. Gastric Cancer. 2022 (May 7). Doi: 10.1007/s10120-022-01298-6

Key clinical point: Firstline trastuzumab-based chemotherapy shows poorer survival in patients with rescued vs initially human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer.

Major finding: The median follow-up duration was 47.6 months. Rescued HER2-positive patients had a higher rate of immunohistochemistry (IHC) score 2+/in situ hybridization-positive (ISH+; 37.0%) tumors. The median progression-free survival (PFS; 5.7 vs 8.4 months; P = .034) and overall survival (OS; 11.3 vs 16.7 months; P = .02) were significantly shorter in IHC 2+/ISH+ vs IHC 3+ patients. Rescued vs initially HER2-positive patients had worse PFS (5.4 vs 7.8 months; P = .017) and OS (10.4 vs 16.3 months; P = .036).

Study details: A retrospective analysis of 153 patients with HER2-positive advanced gastric cancer who received first-line trastuzumab-based chemotherapy.

Disclosures: No funding source was identified for this work. The authors received consulting fees and honoraria. JH Cheon was the founder and shareholder of Novomics.

Source: Bang K et al. Association between HER2 heterogeneity and clinical outcomes of HER2-positive gastric cancer patients treated with trastuzumab. Gastric Cancer. 2022 (May 7). Doi: 10.1007/s10120-022-01298-6

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Carbon nanoparticle suspension lymphography-guided distal gastrectomy improves lymph node detection rate

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Key clinical point: Carbon nanoparticle suspension lymphography-guided distal gastrectomy improves postoperative lymph node detection rate in patients with gastric cancer undergoing gastrectomy.

Major finding: A higher mean number of lymph nodes were detected with vs without carbon nanoparticle suspension injection (CNSI; 59.6 vs 30.0; P < .001). A higher number of lymph nodes were detected in black- vs nonblack-stained stations (9.2 vs 3.5 lymph nodes per station; P < .001).

Study details: This was a retrospective cohort study including 156 propensity score-matched patients with clinical T1-T4 gastric cancer who underwent laparoscopic or robotic distal gastrectomy with or without (conventional group) CNSI between May 2019 and December 2020.

Disclosures: This study was supported by the University Research Project of Hebei Province and the Medical Research Project of Hebei Province, China. The authors declared no conflicts of interest.

Source: Tian Y et al. Assessment of carbon nanoparticle suspension lymphography–guided distal gastrectomy for gastric cancer. JAMA Netw Open. 2022;5(4):e227739 (Apr 18). Doi: 10.1001/jamanetworkopen.2022.7739

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Key clinical point: Carbon nanoparticle suspension lymphography-guided distal gastrectomy improves postoperative lymph node detection rate in patients with gastric cancer undergoing gastrectomy.

Major finding: A higher mean number of lymph nodes were detected with vs without carbon nanoparticle suspension injection (CNSI; 59.6 vs 30.0; P < .001). A higher number of lymph nodes were detected in black- vs nonblack-stained stations (9.2 vs 3.5 lymph nodes per station; P < .001).

Study details: This was a retrospective cohort study including 156 propensity score-matched patients with clinical T1-T4 gastric cancer who underwent laparoscopic or robotic distal gastrectomy with or without (conventional group) CNSI between May 2019 and December 2020.

Disclosures: This study was supported by the University Research Project of Hebei Province and the Medical Research Project of Hebei Province, China. The authors declared no conflicts of interest.

Source: Tian Y et al. Assessment of carbon nanoparticle suspension lymphography–guided distal gastrectomy for gastric cancer. JAMA Netw Open. 2022;5(4):e227739 (Apr 18). Doi: 10.1001/jamanetworkopen.2022.7739

Key clinical point: Carbon nanoparticle suspension lymphography-guided distal gastrectomy improves postoperative lymph node detection rate in patients with gastric cancer undergoing gastrectomy.

Major finding: A higher mean number of lymph nodes were detected with vs without carbon nanoparticle suspension injection (CNSI; 59.6 vs 30.0; P < .001). A higher number of lymph nodes were detected in black- vs nonblack-stained stations (9.2 vs 3.5 lymph nodes per station; P < .001).

Study details: This was a retrospective cohort study including 156 propensity score-matched patients with clinical T1-T4 gastric cancer who underwent laparoscopic or robotic distal gastrectomy with or without (conventional group) CNSI between May 2019 and December 2020.

Disclosures: This study was supported by the University Research Project of Hebei Province and the Medical Research Project of Hebei Province, China. The authors declared no conflicts of interest.

Source: Tian Y et al. Assessment of carbon nanoparticle suspension lymphography–guided distal gastrectomy for gastric cancer. JAMA Netw Open. 2022;5(4):e227739 (Apr 18). Doi: 10.1001/jamanetworkopen.2022.7739

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