Efficacy and Safety of Weekly Paclitaxel Plus Vistusertib vs Paclitaxel Alone in Patients With Platinum-Resistant Ovarian High-Grade Serous Carcinoma

Banerjee, Susana; Giannone, Gaia; Ennis, Darren; Glasspool, Rosalind; Herbertson, Rebecca; Krell, Jonathan; Riisnaes, Ruth; Mirza, Hasan; Cheng, Zhao; McDermott, Jacqueline; Green, Clare; Kristeleit, Rebecca; George, Angela; Gourley, Charlie; Lewsley, Liz-Anne; Rai, Debbie; Banerji, Udai; Hinsley, Samantha; McNeish, Iain A.

doi:10.1001/jamaoncol.2022.7966

“…The Original Investigation titled “Efficacy and Safety of Weekly Paclitaxel Plus Vistusertib vs Paclitaxel Alone in Patients With Platinum-Resistant Ovarian High-Grade Serous Carcinoma: The OCTOPUS Multicenter, Phase 2, Randomized Clinical Trial,” published online March 16, 2023, in the May 2023 print issue, has changed license status to open access (CC-BY-NC-ND license). This article has been updated online.…”

mentioning

confidence: 99%

Change to Open Access Status

2023

JAMA Oncol

0

View full text Add to dashboard Cite

show abstract

“…Likewise, an adequate assessment of subpopulations according to specific characteristics—such as biomarkers—requires a minimum sample size of 50 patients per group . The OCTOPUS study would not meet this criterion. Thirteen patients expressed low PTEN, and 55 expressed high PTEN.…”

mentioning

confidence: 99%

“…To the Editor The OCTOPUS randomized clinical trial recently reported in JAMA Oncology by Banerjee et al compared the combination of weekly paclitaxel plus vistusertib (wP+V) vs paclitaxel monotherapy in patients with platinum-resistant ovarian high-grade serous carcinoma (PR-HGSC). A progression-free survival (PFS) improvement from wP+V was predicted for patients with low tumor cell phosphatase and tensin homolog (PTEN) expression.…”

mentioning

confidence: 99%

See 1 more Smart Citation

Biomarker Analysis of Vistusertib Plus Paclitaxel Regimen

Gil-Sierra,

Briceño-Casado,

Moreno-Ramos

2023

JAMA Oncol

0

View full text Add to dashboard Cite

In Reply We appreciate the comments by Dr Heinrichs regarding our cohort study evaluating the incidence, timing, and factors associated with suicide after cancer surgery. 1 In our study, we found that patients undergoing cancer operations had a statistically significantly higher incidence of suicide compared with the general population. We suggested that the elevated suicide incidence among these patients may be attributed to feelings of hopelessness, depression, loss of function, and poor quality of life following cancer operations. Dr Heinrichs expressed that some patients in our study may have chosen to end their life to stop suffering related to terminal cancer, rather than because of underlying psychiatric morbidity or a lack of social support.While we agree that some patients may choose to end their life to stop suffering related to terminal cancer, we would like to point out that over 91% of patients in our study cohort who died of suicide had nonmetastatic disease at the time of cancer surgery, with over 50% of patients having early-stage, localized disease. 1 These patients were not facing terminal cancer at the time of surgery and most likely chose to undergo surgery with the intent of undergoing curative-intent treatment that could significantly extend survival.It is possible that some patients developed distant recurrence during follow-up after cancer surgery and were then deemed to have terminal cancer at that time. Cancers with lower overall survival rates (eg, pancreatic, esophageal, brain, and stomach cancers) have been reported to have higher rates of recurrence after surgery, 2,3 which often occurs at distant sites and is associated with very poor prognosis. In our study, 1 we found that cancers with lower 5-year overall survival rates were associated with higher standardized mortality ratios of suicide; these data may suggest a possible association between recurrence and suicide risk after cancer surgery. It is worth noting, however, that 7% of suicides occurred within 3 months after surgery and 12% of all suicides occurred within 6 months after cancer surgery. Notably, this period of time is before many patients undergo their first postoperative surveillance scan (and thus prior to when a recurrence would be identified). 4,5 For these patients, it is less likely that the decision to end their life was made to avoid impending and unavoidable cancerrelated death.Ultimately, we believe that the findings of our study 1 highlight the importance of recognizing that suicide is a notable risk after cancer surgery and the need to ensure that patients have sufficient psychosocial support during postoperative recovery. Future research should focus on understanding contributing factors to suicide after cancer surgery and the extent to which recurrence after cancer surgery affects suicide risk. Future research should also focus on differentiating between patients who choose to end their life after surgery because they are facing terminal cancer vs patients who choose to do so due to underlying psychiatri...

show abstract

“…Indeed, in our study, 70 women per group were recruited, which would meet the minimum sample size mentioned by Gil-Sierra and colleagues. However, as with all translational analyses, some samples failed the quality checks and were unusable for further analyses.…”

mentioning

confidence: 99%

Biomarker Analysis of Vistusertib Plus Paclitaxel Regimen—Reply

Giannone,

McNeish,

Banerjee

2023

JAMA Oncol

Self Cite

0

View full text Add to dashboard Cite

In Reply We appreciate the comments by Dr Heinrichs regarding our cohort study evaluating the incidence, timing, and factors associated with suicide after cancer surgery. 1 In our study, we found that patients undergoing cancer operations had a statistically significantly higher incidence of suicide compared with the general population. We suggested that the elevated suicide incidence among these patients may be attributed to feelings of hopelessness, depression, loss of function, and poor quality of life following cancer operations. Dr Heinrichs expressed that some patients in our study may have chosen to end their life to stop suffering related to terminal cancer, rather than because of underlying psychiatric morbidity or a lack of social support.While we agree that some patients may choose to end their life to stop suffering related to terminal cancer, we would like to point out that over 91% of patients in our study cohort who died of suicide had nonmetastatic disease at the time of cancer surgery, with over 50% of patients having early-stage, localized disease. 1 These patients were not facing terminal cancer at the time of surgery and most likely chose to undergo surgery with the intent of undergoing curative-intent treatment that could significantly extend survival.It is possible that some patients developed distant recurrence during follow-up after cancer surgery and were then deemed to have terminal cancer at that time. Cancers with lower overall survival rates (eg, pancreatic, esophageal, brain, and stomach cancers) have been reported to have higher rates of recurrence after surgery, 2,3 which often occurs at distant sites and is associated with very poor prognosis. In our study, 1 we found that cancers with lower 5-year overall survival rates were associated with higher standardized mortality ratios of suicide; these data may suggest a possible association between recurrence and suicide risk after cancer surgery. It is worth noting, however, that 7% of suicides occurred within 3 months after surgery and 12% of all suicides occurred within 6 months after cancer surgery. Notably, this period of time is before many patients undergo their first postoperative surveillance scan (and thus prior to when a recurrence would be identified). 4,5 For these patients, it is less likely that the decision to end their life was made to avoid impending and unavoidable cancerrelated death.Ultimately, we believe that the findings of our study 1 highlight the importance of recognizing that suicide is a notable risk after cancer surgery and the need to ensure that patients have sufficient psychosocial support during postoperative recovery. Future research should focus on understanding contributing factors to suicide after cancer surgery and the extent to which recurrence after cancer surgery affects suicide risk. Future research should also focus on differentiating between patients who choose to end their life after surgery because they are facing terminal cancer vs patients who choose to do so due to underlying psychiatri...

show abstract

Efficacy and Safety of Weekly Paclitaxel Plus Vistusertib vs Paclitaxel Alone in Patients With Platinum-Resistant Ovarian High-Grade Serous Carcinoma

Cited by 11 publications

References 46 publications

Change to Open Access Status

Change to Open Access Status

Biomarker Analysis of Vistusertib Plus Paclitaxel Regimen

Biomarker Analysis of Vistusertib Plus Paclitaxel Regimen—Reply

Contact Info

Product

Resources

About