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This randomized clinical trial assesses whether etoposide plus cisplatin or irinotecan plus cisplatin is a more effective treatment regimen in terms of overall survival in patients with advanced neuroendocrine carcinoma of the digestive system.
In Reply We thank the authors for their thoughtful comments on the ORATOR2 trial. The comments can be divided into 4 main themes: surgical credentialing, margin requirements, treatment-related deaths as extremely rare “black swan” events, and questioning the requirements for adjuvant therapy after transoral surgery (TOS). We address each of these in turn.
In Reply We appreciate the suggestions of Yatsuzuka and Murakami regarding our study that reported the risk of comorbidities in patients with palmoplantar pustulosis (PPP) compared with those with psoriasis vulgaris (PSV) or pompholyx. They suggested 2 additional subgroup analyses based on subtypes of PPP.
To the Editor The declared aim of the ORATOR2 randomized clinical trial recently reported by Palma et al in JAMA Oncology was to compare outcomes in patients with human papillomavirus–associated oropharyngeal cancer treated with primary radiotherapy (RT) vs primary transoral surgical (TOS) approach and to provide a high level of evidence to guide the selection of treatment options for a subsequent phase 3 trial. To have a direct comparison, a trial (eg, EORTC 1420) should aim to compare 2 samples receiving a single-treatment modality with a limited proportion of patients requiring adjuvant treatment for the lymph node status (multiple lymph nodes or greater than 3 cm) and/or adverse features, such as positive margins and extranodal extension discovered on the surgical specimen. However, ORATOR2 seems to fail these goals because 78% of the TOS arm required adjuvant RT. In fact, these patients received a median dose of 52 Gy compared with 60 Gy of the RT arm. Moreover, all patients underwent neck dissection, and 65% patients underwent prophylactic tracheotomy. In this scenario, the increased risk of complications after surgery is intuitive rather than evidenced. Because 2 treatment-related deaths were described (1 surgical site hemorrhage and 1 spondylodiscitis occurred after adjuvant RT), the authors concluded that TOS was associated with an unacceptable risk of grade 5 toxic effects. However, the high (7.4%) treatment-related mortality rate does not correspond to our personal experience and to literature data. A recent meta-analysis including more than 5700 transoral robotic surgeries reported a postoperative bleeding rate of 5.8%, with 2.9% of massive hemorrhages and a consequent 0.17% of bleeding-related deaths. The GETTEC study, also cited by Palma et al, described a total of 7 cases of postoperative spondylodiscitis in more than 1084 transoral robotic surgeries for an incidence of 0.6% and a related mortality of 0.3%. Furthermore, all cases included in that series were posterior pharyngeal wall tumors, and 5 patients of this cohort underwent adjuvant RT. In the ORATOR2 trial, the spondylodiscitis occurred 110 days after surgical treatment of a tonsillar cancer, and it seemed to be unrelated to the surgical procedure itself but most likely a consequence of the adjuvant RT.
To the Editor We have read with great interest the article by Kim et al comparing the risks for several comorbidities between Korean patients with palmoplantar pustulosis (PPP) and psoriasis vulgaris (PSV) or pompholyx. They conducted a large cohort study that suggested that patients with PPP have an overlapping comorbidity profile with patients with PSV; however, the risk for comorbidities may substantially differ. Although whether PPP is a distinct entity or a subtype of psoriasis remains an ongoing debate, their findings deepen this discussion. We speculate that adding subgroup analyses based on PPP subtypes could potentially lead to more significant findings.
To the Editor Palma et al recently reported results from a phase 2 randomized clinical trial comparing transoral surgery (TOS) with neck dissection vs radiotherapy with or without chemotherapy in 61 patients with early-stage p16-positive oropharyngeal cancer (OPC) at 9 institutions across Canada and Australia. Among 27 patients who underwent TOS, there were 2 treatment-related grade 5 toxic events (7.4%): oropharyngeal hemorrhage on postoperative day 4 and cervical vertebral osteomyelitis on postoperative day 110. The initial ORATOR trial reported 1 grade 5 oropharyngeal bleed among 34 patients who underwent transoral robotic surgery (TORS). In combination, the overall treatment-related death rate of patients who underwent surgery in the ORATOR trials was 4.9%.
This randomized clinical trial evaluates the combination of psychotherapy with psilocybin vs active placebo in patients with alcohol use disorder.
To the Editor We commend Palma et al for presenting a randomized comparison of primary surgery vs radiation therapy for human papillomavirus–positive oropharyngeal cancer. However, we would caution against generalized applicability of ORATOR2 outcomes.
This randomized clinical trial explores if enhanced self-measured blood pressure (SMBP) paired with a connected smartphone application is superior to standard SMBP for blood pressure reduction or patient satisfaction.
Fewer venous thromboembolic events occurred with enoxaparin, but distal deep venous thrombosis accounted for most of the difference.
Autore/Fonte: Intensive Care Med
This cost-utility analysis evaluates the cost-effectiveness of rituximab biosimilars vs mycophenolate mofetil as a first-line steroid-sparing agent for moderate to severe pemphigus vulgaris.
This randomized clinical trial evaluates the safety and efficacy of at-home transcranial direct current stimulation in treating inattention in adults with attention-deficit/hyperactivity disorder.
This systematic review and meta-analysis compares the performance of the log-rank test vs the MaxCombo and difference in restricted mean survival time tests in immuno-oncology trials.
This randomized clinical trial compares treatment with neoadjuvant modified FOLFIRINOX with or without hypofractionated radiation therapy with historical data and establishes standards for therapy in borderline resectable pancreatic ductal adenocarcinoma.
This randomized clinical trial assesses the effect of a comprehensive telehealth intervention vs a simpler telehealth approach for patients with persistently poorly controlled type 2 diabetes.
