Video-assisted mediastinoscopic lymphadenectomy (VAMLA): Mature results for staging non-small cell lung cancer with normal mediastinum.

OBJECTIVES: The aim of this study is to analyze the accuracy of video-assisted mediastinoscopic lymphadenectomy (VAMLA) and the unsuspected (u) N2/3 rates in patients with non-small cell lung cancer (NSCLC) and normal mediastinum by integrated positron emission tomography-computed tomography. METHODS: Prospective observational single-center study of 603 consecutive VAMLAs from 2010 to 2022. EXCLUSION CRITERIA: other indications (n = 32), tumors different from NSCLC (n = 91), and clinical (c) N2/3 tumors by positron emission tomography-computed tomography (n = 46). Systematic nodal dissection was the gold standard to validate negative VAMLAs. Those patients with negative VAMLA and missing reference standard test were excluded. uN2/3 rates were analyzed in the global series and in the subgroups of tumors according to their clinical nodal and tumor categories. Pathologic findings were reviewed, and staging values were calculated. RESULTS: Three hundred eighty-three patients with cN0/1 NSCLC underwent VAMLA. Staging values of VAMLA were: sensitivity, 0.98 (95% CI, 0.92-0.99); negative predictive value, 0.99 (95% CI, 0.98-1); and diagnostic accuracy, 0.99 (95% CI, 0.98-1). The uN2/3 rate for the whole series (N = 383) was 18.8%. The uN2/3 rates according to presurgical nodal and tumor categories determined by positron emission tomography computed tomography were: 3.6% (4 out of 111) in cT1N0; 16.3% (18 out of 110) in cT2N0; 10.25% (4 out of 39) in cT3N0; and 32% (7 out of 22) in cT4N0. Forty-two percent (39 out of 93) in cN1; complication rate was 7%. CONCLUSIONS: This series of NSCLC with normal mediastinum staged by VAMLA demonstrates a high accuracy of this technique and a high rate of uN2/3 disease (specially in cN1 and cT4N0). VAMLA could be considered the reference staging procedure for staging cN0/1 NSCLC.

Five-year antibody persistence and safety following a booster dose of combined Haemophilus influenzae type b-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine.

BACKGROUND: Booster vaccination with the combined Haemophilus influenza type b-Neisseria meningitides serogroup C-tetanus toxoid vaccine (Hib-MenC-TT) has been reported to induce different MenC antibody responses depending on the priming vaccines, with a possible impact on long-term protection. Here, the five-year persistence of immune responses induced by a booster dose of Hib-MenC-TT was evaluated in toddlers primed with either Hib-MenC-TT or MenC-TT. METHODS: This is the follow-up of a phase III, open, randomized study, in which a Hib-MenC-TT booster dose was given at 13.14 months of age to toddlers primed with either 3 doses of Hib-MenC-TT or 2 doses of MenC-TT in infancy. Children in the control group had received 3 primary doses and a booster dose of MenC-CRM197. Functional antibodies against MenC were measured by a serum bactericidal assay with rabbit complement (rSBA-MenC) and antibodies against Hib polyribosylribitol phosphate by enzyme-linked immunosorbent assay. Serious adverse events considered by the investigator to be possibly related to vaccination were to be reported throughout the study. RESULTS: At 66 months postbooster, rSBA-MenC titers ≥8 were retained by 82.6% of children primed with Hib-MenC-TT, 94.1% of children primed with MenC-TT, and 60.9% of children in the control group. All children who received the Hib-MenC-TT booster dose retained anti- polyribosylribitol phosphate concentrations ≥0.15 µg/mL. No serious adverse events considered possibly related to vaccination were reported. CONCLUSIONS: There is evidence of good antibody persistence against MenC and Hib for more than five years postbooster vaccination with Hib-MenC TT in toddlers primed with Hib-MenC-TT or MenC-TT.

Combined Haemophilus Influenzae type B-Neisseria meningitidis serogroup C vaccine is immunogenic and well tolerated in preterm infants when coadministered with other routinely recommended vaccines.

BACKGROUND: Preterm infants are at greater risk of morbidity from vaccine-preventable diseases. Therefore, their responses to vaccination are of particular interest. METHODS: In this open, controlled, Spanish multicenter study, we assessed immunogenicity and safety following primary vaccination of 163 preterm infants (n = 56, <31 weeks' gestation; n = 107, 31-36 weeks' gestation) and 150 full-term infants (>36 weeks' gestation), with Haemophilus Influenzae type B (Hib)-MenC-TT, DTaP(diphtheria-tetanus-acellular pertussis vaccine)-HepB-IPV, and PCV7 at 2 to 4-6 months of age followed by booster vaccination at 16 to 18 months of age. Serum bactericidal activity (rabbit complement) against MenC, and antibodies to Hib and hepatitis b (anti-HBs) were determined. Local/general symptoms were assessed after each vaccination via diary cards. Serious adverse events were recorded throughout the study. RESULTS: There were no statistically significant differences between preterm and full-term infants in either Hib or MenC seroprotection rates or geometric mean concentrations at 1 month postdose 3, before or 1 month postbooster. Postdose 3, >99% of participants had seroprotective anti-HBs antibody concentrations. Anti-HBs geometric mean concentrations was significantly lower in the <31-week group compared with other groups and this difference persisted until 16 to 18 months of age. Hib-MenC-TT vaccine was well tolerated at all ages. There was one death caused by meningococcal serogroup-B sepsis (full term). No serious adverse events were assessed by the investigator as being vaccine related. CONCLUSIONS: Hib-MenC-TT vaccine had a similar immunogenicity and safety profile in preterm and full-term infants. These results demonstrate that preterm infants can be safely vaccinated with Hib-MenC-TT at the recommended chronologic age without impacting the responses to the Hib and MenC antigens.