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Introduction: To evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of ZRC-3277 (pertuzumab biosimilar) with Perjeta® (pertuzumab) in previously untreated patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC)., Patients and Methods: This phase III, multicenter, double-blind study across 38 sites in India randomized (1:1) patients with HER2-positive MBC in either the ZRC-3277 or Perjeta® group. Both groups also received trastuzumab and docetaxel. Of 268 enrolled patients, mITT population had 243 patients (119 and 124 in the ZRC-3277 and Perjeta® groups, respectively). The primary objective was to compare the between-group objective response rate (ORR) after 6 cycles of treatment. ORR was determined by evaluating scans of computed tomography or magnetic resonance imaging following Response Evaluation Criteria in Solid Tumor (RECIST 1.1). Two-sided 95% confidence interval (95% CI) for the difference in ORR was determined to evaluate the noninferiority of ZRC-3277 to Perjeta®. The secondary outcomes included the assessment of PK, immunogenicity, and safety between the 2 groups., Results: In the mITT population, 104 (87.39%) and 114 (91.94%) participants achieved the ORR in the ZRC-3277 and Perjeta® groups, respectively. For predefined -15% noninferiority margin, obtained 2-sided 95% CIs (-12.19%, 3.11%) for the difference in ORR (-4.55%) between the 2 groups demonstrated the noninferiority of ZRC-3277 to Perjeta®. PK, immunogenicity, and safety were not significantly different between the 2 groups., Conclusion: Efficacy, PK, immunogenicity, and safety profiles of ZRC-3277 was found to be similar to those of Perjeta®., Competing Interests: Disclosure Deven Parmar is an employee of Zydus Therapeutics Inc, USA, whereas Maulik Doshi and Rahul Shrivastava are employees of Zydus Lifesciences Ltd. All other authors declare no conflict of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Aim: The aim of the study is to compare the advantages and disadvantages of non-suturing anastomotic methods over conventional microsuturing for microvascular venous anastomosis., Materials and Methods: All patients reporting to the institute for hard and soft tissue reconstruction (Primary/secondary) were enrolled in the study. Patients with systemic comorbidities, peripheral vascular diseases, or anatomical aberration of the indicated donor site were excluded from the study. The patients selected for the study were randomly allocated to five groups of different techniques of venous anastomosis, namely Group I (conventional microsuturing), II (fibrin sealant reinforced microsuturing), III (couplers), IV (staplers), V (Laser Assisted Vascular Anastomosis (LAVA)). Intraoperative anastomotic time, flap ischaemic time, patency and leakage were the parameters that were assessed for all five groups., Results: 80 Patients were randomly allocated to five groups and each group comprised 16 patients. The mean ischaemic time and standard deviation of Group I and Group II were 256.19 ± 10.622 min and 255.19 ± 11.083 min, and for groups III, IV, and V were 193.38 ± 9.972 min, 139.06 ± 6.413 min, and 139.31 ± 6.364 min respectively (p < 0.001). Mean anastomotic time and standard deviation were 19.813 ± 1.5366 min in Group I and 20.281 ± 1.6514 min in Group II. The non-sutured anastomosis groups III, IV, and V showed a mean anastomotic time of 5.375 ± 0.9876 min, 4.175 ± 0.7664 min, and 3.856 ± 0.867 min respectively (p value < 0.001). In Groups I and II, 18.8% of patients had delayed patency and in Groups III, IV and V, immediate patency was observed in all subjects (p value 0.030). In Groups I and II, 18.8% and 6.3 % of patients respectively had leakage, whereas all patients in Groups III, IV, V had no leakage from the anastomotic site (p value 0.119)., Conclusion: Based on the results of the study, non-suturing techniques should be preferred over microsuturing technique whenever appropriate for venous anastomosis., (Copyright © 2020 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.)

Single crystal EPR studies on Cu(II) doped paramagnetic host lattices, hexaimidazole M(II) dichloride tetrahydrate (M=Co and Ni), isomorphous with M=Zn, have been carried out from room temperature to 77K to understand the nature of Jahn-Teller (JT) distortion in these paramagnetic host systems. The paramagnetic impurity, doped in the present two paramagnetic host lattices, shows anisotropic EPR spectra with superhyperfine from ligands, even at room temperature. An interesting observation noticed in the EPR spectra at room temperature is that there are more resonances corresponding to the second site in the paramagnetic hosts than in the diamagnetic host at 4.2K. This difference in behavior between the diamagnetic and paramagnetic host lattices indicates a change in the depth of the JT valleys. The spin Hamiltonian parameters are evaluated for Cu(II) ion in both the host lattices and the relaxation times have been calculated for the ion in cobalt host lattice only.

The electron paramagnetic resonance spectroscopic investigation of VO(II)-doped zinc ammonium trihydrogen bis(orthophosphate) monohydrate single crystal has been carried out at 300K. The single crystal, rotated along the three orthogonally crystallographic axes, have yielded spin Hamiltonian parameters g and A as: g(xx)=1.978, g(yy)=1.974, g(zz)=1.925 and A(xx)=7.4, A(yy)=7.8, A(zz)=19.4 mT. These spin Hamiltonian parameters reflect a slight deviation from axially symmetry to rhombic, which is elucidated by the interstitial occupation of the vanadyl ion. The isofrequency plots and EPR spectra at few orientations have been simulated using the calculated spin Hamiltonian parameters. The Fermi contact parameter (kappa) and dipolar interaction parameter (P) have been calculated as 0.857 and -128 x 10(-4)cm(-1), respectively. The percentage of metaloxygen bond has been identified as 20%.

Single crystal EPR study of VO(II)-doped magnesium potassium phosphate hexahydrate has been carried out at room temperature. Single crystal rotations in the three orthogonal planes indicate that the paramagnetic impurity has entered the lattice in place of magnesium ions by replacing the equatorial and axial coordinated water molecules. The spin Hamiltonian parameters obtained for the two substitutional sites are: site 1: g1=1.9800, g2=1.9774, g3=1.9296, A1=7.25 mT, A2=8.09 mT, A3=18.69 mT and site 2: g1=1.9802, g2=1.9765, g3=1.9296, A1=6.82 mT, A2=8.48 mT, A3=18.75 mT, respectively. Superhyperfine, from protons of ligand water molecules, has been observed at certain orientations. It has been concluded that VO bond directions of the two substitutional ions are orthogonal to each other.

Single crystal electron paramagnetic resonance (EPR) studies of Mn(II) doped zinc potassium phosphate hexahydrate have been carried out at room temperature. Single crystal rotations along the three orthogonal axes indicate orthorhombic symmetry with spin-Hamiltonian parameters as: g(xx) = 1.9997; g(yy) = 1.9538; g(zz) = 1.9524, D(xx) = 15.49 mT; D(yy) = 0.22 mT; D(zz) = -15.71 mT, A(xx) = 11.70 mT; A(yy) = 10.53 mT; A(zz) = 10.42 mT and a = 0.8 x 10(-4) cm(-1). A large E term indicates considerable distortion from axial symmetry. The impurity is found to enter the lattice substitutionally. The distortion axis for the impurity has been identified along one of the Zn-O bond directions in the crystal.