All’inizio pensava fossi sposato, perché sui social mettevo foto con mia sorella e il mio fratellino con cui ho 24 anni di differenza. The first group showed a significantly better OS (26 versus 21 months, p < 0.01; Hazard Ratio (HR) = 0.72; 95% Confidence Interval (CI) = 0.68–0.78). Ecco le parole di Salvatore, in un’intervista a Vanity Fair: “Sogno di creare una famiglia che sia mia. A patient who does not meet eligibility criteria and is inadvertently included in this program can continue program treatment if he/she has a clinical benefit according to physician opinion. The primary tumor must be surgically resectable, defined as: - no involvement (abutment or encasement) of the major arteries (celiac, common hepatic and/or SMA); - no involvement or <180° interface between tumor and vessel wall of the portal vein, superior mesenteric vein and/or portal vein/splenic vein confluence. Clinicaltrial.gov: NCT03528785. View or download all content the institution has subscribed to. Physical examination, tumor marker examination, and CT scan were given every 3 months. Afficher les profils des personnes qui s’appellent Paola Rossi. Incidence of serious adverse events (SAEs), using common toxicities adverse events criteria (CTCAE) version 4.0 (time frame every 2 weeks during treatment). Number of participants achieving pathological complete response (pCR) (time frame up to 2 years). Blood samples and archived tumor tissues from the patients of the study will be collected and analyzed to survey potential predictive/prognostic biomarkers that may correlate with nal-IRI PK, toxicity, and/or disease response. Solid clinical evidence is emerging to demonstrate an improved tumor resectability or patient survival duration with preoperative therapy compared to standard treatment in resectable pancreatic cancer. However, individual enquirers can experience significant steps at critical stages and, thus, gain greater insight and understanding of the complexity of the phenomenon under investigation.59 Several large randomized trials are currently addressing the potential advantage of pre or perioperative versus standard postoperative strategies by using regimens more commonly approved for the metastatic setting (ClinicalTrials.com identifiers: NCT02172976, NCT04340141, NCT02919787, NCT02959879). The nITRO trial is a phase II, single-arm, open-label study to assess the safety and the activity of nal-IRI with fluorouracil/leucovorin (5-FU/LV) and oxaliplatin in the perioperative treatment of patients with resectable pancreatic cancer. In addition, other radiographic or scintigraphy procedures, as deemed appropriate by the treating physician, may be performed to assess sites of neoplastic involvement. Atropine may be prescribed prophylactically for patients who experience acute cholinergic symptoms in previous cycles. Therapy for diarrhea: Diarrhea can occur early (onset in less than 24 h after starting nal-IRI) or late (more than 24 h). This design yields a type I error rate of 0.05 and power of 0.8 when the true R0 resection rate is 55%. I have read and accept the terms and conditions, View permissions information for this article, *These authors contributed equally to the work. According to the British Royal College of Pathology (RCPath) guidelines (www.rcpath.org), microscopic tumor clearance for at least 1 mm in all transection (the pancreatic duct margin, the bile duct margin, the proximal duodenal/stomach margin, the distal duodenal margin) and circumferential margins (the posterior pancreatic surface, the medial margin and the anterior surface) is required to confirm radicality and be considered as a meaningful prognostic and predictive factor. 1.3m Followers, 574 Following, 2,712 Posts - See Instagram photos and videos from Salvatore Esposito (@salvatoreesposito) Drug carrier technologies represent a rational strategy to improve the pharmacokinetics and biodistribution of irinotecan while protecting it from premature metabolism. Paolo Rossi, fidanzata Salvatore Esposito, chi è? I due sono stati visti spesso in giro per varie regioni, recentemente a Roma. Work in the Digestive Molecular Clinical Oncology Research Unit is partially supported by investigator grants nos. The first cycle day 1 is a fixed day; subsequent doses should be administered on the first day of each cycle ± 2 days. Based on the NAPOLI-1 trial, in October 2015, nal-IRI (Onivyde) has been approved by the US Food and Drug Administration (FDA), in combination with 5FU/LV, for the treatment of patients with metastatic pancreatic cancer after disease progression following gemcitabine-based therapy.35,36, In a recent phase I/II trial has been assessed the safety, tolerability, and dose-limiting toxicities of nal-IRI+5-FU/LV + oxaliplatin for the first-line treatment of patients with locally advanced and metastatic pancreatic cancer, and to determine phase III dosing (NCT02551991). The safety profile suggested a manageable regimen with a promising anti-tumor activity (DCR16wk of 71.9%, sum of Complete Response (CR) + Partiale Response (PR) + Stable Disease (SD): 81.3%, and ORR of 34%).37. In the case of a vascular resection, the entire transection margins of the vessel should be validated.48 In more recent studies, the introduction of a standardized protocol for the evaluation of pancreatic cancer resection specimens led to significantly lower R0 resection rates than expected.41,49,52 In this regard, we recently conducted a retrospective evaluation by using these guidelines of 131 patients who underwent up-front resection for pancreatic cancer from February 2018 to March 2019. For more information view the SAGE Journals Sharing page. ondansetron or granisetron) should be administered to all patients as premedications unless contraindicated for the individual patient. Prevention of alopecia with cold cap or of stomatitis with iced mouth rinses is allowed. Mix the diluted solution by gentle inversion. Premedication should be given on the day of treatment, starting at least 30 min before administration of the therapy. Pancreatic cancer: systemic combination therapies for a heterogeneous disease, From genetic alterations to tumor microenvironment: the Ariadne’s string in pancreatic cancer, Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial. The authors also thank Dr. Hayley Louise Salt for data entry and administrative support. Paola Rossi, chi è la fidanzata di Salvatore Esposito? Serum chemistry should include electrolytes (sodium, potassium, chloride and bicarbonate), Blood Urea Nitrogen (BUN), serum creatinine, clearance creatinine, glucose, direct and total bilirubin, aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), uric acid, total protein, albumin, calcium, magnesium and phosphate. Part of the work is performed at the Laboratorio Universitario di Ricerca Medica (LURM) Research Center, University of Verona. Ethics approval and consent to participate, Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States, Emerging pathways and future targets for the molecular therapy of pancreatic cancer, Mechanisms of resistance to chemotherapeutic and anti-angiogenic drugs as novel targets for pancreatic cancer therapy. Loperamide should not be used for more than 48 consecutive hours due to the risk of paralytic ileus. Nal-IRI treatment should be delayed until diarrhea resolves to ⩽ grade 1 (2–3 stools/day more than pre-treatment frequency). The treating physician is responsible for obtaining investigational review board (IRB)/ethics committee (EC) approvals as locally required, unless a central EC approval has been obtained. fonte:https://www.gossipblog.it/post/619492/paola-rossi-chi-e-fidanzata-salvatore-esposito, Cristiana dell’Anna – “Patrizia” Forse in Gomorra 5. A 12-lead ECG will be performed at screening, day 1 and day 15 of cycle 1 and follow-up. Despite recent biological insight and therapeutic advances, the prognosis of pancreatic cancer patients remains poor even in the resectable setting and this is largely correlated to the limited efficacy of available treatments. If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. E poi foto con gli amici, i parenti e poi le ultime, quelle condivise in quarantena, con gli immancabili dolci della tradizione pasquale. La giovane prenderà la laurea in Giurisprudenza quest’anno e quando non è in Spagna per studio, convive con l’attore napoletano in Italia. Table 1. A Simon’s two-stage design will be used. PARIS, FRANCE - APRIL 08: Salvatore Esposito and his wife Paola Rossi attend "Taxi 5" Paris Premierere at Le Grand Rex on April 8, 2018 in Paris, France. Overall resection rate (time frame immediately after surgery). atazanavir, gemfibrozil, indinavir) may also increase systemic exposure of nal-IRI. Some possible reasons for early discontinuation of study treatment include, but are not limited to, the following: patient has radiological evidence of disease progression per RECIST 1.1, patient experiences intolerable toxicity, or an adverse event requiring treatment discontinuation, treatment to be withheld for more than 21 days from the start of next cycle, unless, in the opinion of the treating physician, the patient is receiving benefit from program treatment, the patient experiences an adverse event which requires more than two dose reductions, patient is significantly non-compliant with treatment procedures in the opinion of the treating physician. Antiemetics should also be prescribed as clinically indicated during the program period. If a patient’s dose is reduced during the program due to toxicity, it should remain reduced for the duration of the program; dose should not be re-escalated to an earlier dose. Paola Rossiè una studentessa campana trasferitasi in Spagna sin da giovane, per completare i suoi studi. Dagli scatti pubblicati sul suo profilo Instagram, si intuiscono quali siano le passioni di Paola Rossi. To improve further the outcome achieved with this strategy, more active combination regimens borrowed by the metastatic setting are currently under evaluation as effective preoperative treatments. CT texture analysis of ductal adenocarcinoma downstaged after chemotherapy, Adjuvant and neoadjuvant therapy for pancreatic cancer, Pancreatic cancer: French clinical practice guidelines for diagnosis, treatment and follow-up (SNFGE, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO, ACHBT, AFC), Positive mobilization margins alone do not influence survival following pancreatico-duodenectomy for pancreatic ductal adenocarcinoma, Influence of resection margins on survival for patients with pancreatic cancer treated by adjuvant chemoradiation and/or chemotherapy in the ESPAC-1 randomized controlled trial, Long-term results of partial pancreaticoduodenectomy for ductal adenocarcinoma of the pancreatic head: 25-year experience, Curative resection is the single most important factor determining outcome in patients with pancreatic adenocarcinoma, Impact of resection status on pattern of failure and survival after pancreaticoduodenectomy for pancreatic adenocarcinoma, Resection margins in carcinoma of the head of the pancreas. Adverse events were assessed according to CTCAE version 4.0. 12182 through the Associazione Italiana per la Ricerca sul Cancro (AIRC), by the Ricerca Finalizzata 2016 grant GR-2016-02361134 through the Italian Ministry of Health, and by the ‘Nastro Viola’ and ‘Voglio il Massimo’ associations of patients’ donations to D. Melisi. Particular attention should be paid to areas of possible neoplastic involvement. As used in this protocol, the term ‘informed consent’ includes all informed consent given by patients or their legal representatives (for informed consents see Appendices 1 and 2). Delivering cytotoxic drugs to tumors that are intact and not altered by surgery with resultant local hypoxia, inflammation, and fibrosis, preoperative therapy has the potential to destroy tumor cells, particularly in the periphery of the tumor mass, thereby improving the likelihood of an ultimate R0 resection. Survival follow-up: after the follow-up visit, the patient should continue to be followed for survival status once every 3 months (±14 days) via telephone, email, clinic visit, or medical record review until 36 months after the end of treatment, death, lost to follow-up, withdrawal of consent or study closure, whichever occurs first. This study proposal is designed to address this challenge. Number of participants experiencing perioperative (30-day) mortality or morbidity (time frame up to 30 days from surgery). A female subject is considered to be of childbearing potential unless she is aged ⩾50 years and naturally amenorrhoeic for ⩾2 years, or unless she is surgically sterile. We will evaluate pre and post-treatment levels of transdifferentiation of fibroblasts into activated myofibroblasts, pericyte coverage of the tumor vasculature and microvessel density, fibrotic and collagen content in tumor specimen sections, intratumor nal-IRI, SN-38, CPT-11 concentration. Investigators should complete all routine and standard of care assessments to evaluate for toxicity and symptoms of drug-induced adverse events. Surgery will be performed after receiving at least two cycles of chemotherapy preoperatively planned at up to 12 weeks. Nal-IRI must not be administered to patients with bowel obstruction, until it is resolved. Paola, che era una fan, decise di contattare l’attore su Facebook e i due iniziarono a parlare e a diventare sempre più intimi. Appendix 2. All the patients should take following examinations at baseline: computed tomography (CT) scan and abdominal magnetic resonance imaging (MRI). Adjuvant or neoadjuvant therapy in the treatment in pancreatic malignancies: where are we? Inadequate bone marrow reserves as evidenced by: - Absolute neutrophil count (ANC) ⩽ 1500 cells/μl; or. Moreover, preoperative therapy might allow the delivery of systemic therapy to a higher percentage of patients and with an improved tolerance than in a postoperative setting. The actual dose of nal-IRI to be administered should be determined by calculating the patient’s body surface area (BSA) at the beginning of each cycle. grapefruit juice, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) may increase systemic exposure of nal-IRI. Un curriculum ricco e corposo, che vanta anche alcune esperienze all’estero. Guarda il profilo completo su LinkedIn e scopri i collegamenti di Paola e le offerte di lavoro presso aziende simili. A complete blood count (CBC) will be performed locally, and should include white blood count (WBC) and differential, hemoglobin, hematocrit and platelet count. È il vero valore aggiunto di ognuno di noi. the site you are agreeing to our use of cookies. All serious adverse events (SAEs) occurring during the study treatment period must be reported within 24 h. Follow-up of all patients will be carried out according to our protocol (every 3 months for at least 2 years, every 6 months for years 3–5, then every 12 months for life). Mi ha buttato le braccia al collo e ancora stanno lì”, © WEB365 SRL - Tutti i diritti riservati - Testata Registrata al tribunale di Velletri in data 9-4-2019 N°8/2019, Paola Rossi fidanzata Salvatore Esposito, chi è? The detection of circulating cell-free DNA derived from tumor cells, or ctDNA, right after surgery and its longitudinal monitoring is one of the most promising approaches for predicting prognosis in this setting.57 We will perform deep sequencing [CAncer Personalized Profiling by deep Sequencing, (CAPP-Seq)] analyses58 of plasma cell-free DNA collected before and after resection to determine whether detection of ctDNA is associated with the risk of tumor recurrence. Polychemotherapeutic combinations are valid options for postoperative treatment in patients with good performance status. L’ho vista sbucare da dietro una colonna agli arrivi dell’aeroporto, la prima volta. View the profiles of people named Paola Rossi. All authors read and approved the manuscript. Because of this aggressive biological behavior and the high rate of recurrence after surgical resection and postoperative therapy, increasing interest is growing about pre or perioperative treatments in resectable pancreatic cancer with the aim of expanding the population of patients who may ultimately benefit from resection.20 These strategies might provide an interval of time to assess the biological aggressiveness and the chemoresistance of the disease to avoid an unnecessary surgery in patients who would relapse soon after resection. FOLFIRINOX is an effective choice for first-line treatment in patients affected by advanced pancreatic cancer, and in this setting it achieved a disease control rate (DCR) of 70.2%.12 A small proof-of-concept pilot study recently demonstrated the feasibility of perioperative mFOLFIRINOX in resectable pancreatic cancer. Liposomal irinotecan (Nal-IRI) is irinotecan hydrochloride encapsulated into a nanoliposome drug delivery system (nanoliposomal irinotecan; nal-IRI). Eligible patients with resectable pancreatic cancer will receive a peri-operative treatment with three cycles (3 months) with nal-IRI 50 mg/m2, oxaliplatin 60 mg/m2, LV 200 mg/m2, and 5-FU 2400 mg/m2, days 1 and 15 of a 28 day-cycle before and after surgical resection (Figure 1). A total of 72 patients will be enrolled. In conclusion, the nITRO trial will contribute to strengthen the clinical evidence supporting perioperative strategies in immediately resectable pancreatic cancer patients. In clinical studies, dosing may be held for up to 3 weeks from when it was due, to allow for recovery from toxicity related to the study treatments. Although this study did not demonstrate a statistically significant advantage in OS in the intention-to-treat population, all the secondary endpoints, including disease-free survival and R0 resection rate, were significantly superior with preoperative chemoradiotherapy, suggesting a potential advantage for this approach.25. Members of _ can log in with their society credentials below, Francesca Simionato, Camilla Zecchetto, Valeria Merz, Alessandro Cavaliere, Simona Casalino, Marina Gaule, Mirko D’Onofrio, Giuseppe Malleo, Luca Landoni, Alessandro Esposito, Giovanni Marchegiani, Luca Casetti, Massimiliano Tuveri, Salvatore Paiella, Filippo Scopelliti, Alessandro Giardino, Isabella Frigerio, Paolo Regi, Paola Capelli, Stefano Gobbo, Armando Gabbrielli, Laura Bernardoni, Vita Fedele, Irene Rossi, Cristiana Piazzola, Serena Giacomazzi, Martina Pasquato, Morena Gianfortone, Stefano Milleri, Michele Milella, Giovanni Butturini, Roberto Salvia, Claudio Bassi, and Davide Melisi, Digestive Molecular Clinical Oncology Unit, Section of Medical Oncology, Department of Medicine, University of Verona, Verona, Italy, Department of Radiology, University and Hospital Trust of Verona, Verona, Italy, Department of Surgery, University and Hospital Trust of Verona, Verona, Italy, Department of Surgery, Pancreatic Surgery Unit, Hospital P. Pederzoli, Peschiera del Garda, Italy, Department of Pathology, University and Hospital Trust of Verona, Verona, Italy, Department of Pathology, Hospital P. Pederzoli, Peschiera del Garda, Italy, Endoscopy Unit, University and Hospital Trust of Verona, Verona, Italy, Digestive Molecular Clinical Oncology Research Unit, Department of Medicine, University of Verona, Verona, Italy, Centro Ricerche Cliniche di Verona, University and Hospital Trust of Verona, Verona, Italy, Medical Oncology Unit, University and Hospital Trust of Verona, Verona, Italy, Digestive Molecular Clinical Oncology Unit, Section of Medical Oncology, Department of Medicine, University of Verona, AOUI Verona – Policlinico “G.B. Create a link to share a read only version of this article with your colleagues and friends. Care should be taken not to use in-line filters or any other diluents. Paola ha indicato 3 esperienze lavorative sul suo profilo. This product could help you, Accessing resources off campus can be a challenge. Raccontiamo il successo delle grandi opere cinematografiche e delle serie tv che diventano poi Cult. Paola Rossi è la studentessa campana che ha stregato il cuore di Salvatore Esposito, l’attore diventato noto per avere interpretato il ruolo di Genny Savastano nella serie tv Gomorra. Management of patients with pancreatic adenocarcinoma: national trends in patient selection, operative management, and use of adjuvant therapy, Computational modeling of pancreatic cancer reveals kinetics of metastasis suggesting optimum treatment strategies, EMT and dissemination precede pancreatic tumor formation, Adjuvant therapy for adenocarcinoma of the pancreas: analysis of reported trials and recommendations for future progress. A urine or serum pregnancy test will be obtained for all women of childbearing potential at screening, at the start of each cycle during study treatment and at the follow-up. As a matter of fact, determination of the resection status is part of the pathological examination and it is a critical step of correct staging and planning of postoperative treatments. Proper execution and documentation of the clinical procedures is the responsibility of the treating physician. (Photo by Bertrand Rindoff Petroff/Getty Images) Second-line chemotherapy for advanced pancreatic cancer: which is the best option? All patients will provide written informed consent before enrollment. Paola Rossi, chi è la fidanzata di Salvatore Esposito? The TAMs population and their modulation during nal-IRI treatment will be measured and characterized in pre and post-treatment sample tissues. Any patient who has two dose reductions and experiences an adverse event that would require a third dose reduction should be discontinued from program treatment. The differentiation of mesenchymal precursors in myofibroblasts leads to increased collagen deposition and extracellular matrix remodelling as well as increased interstitial fluid pressure (IFP). Otherwise, 33 additional patients will be accrued for a total of 72. Moreover, this study represents a unique opportunity for translational analyses aimed to identify novel immune-related prognostic and predictive factors in this setting. Antiemetic medications: Dexamethasone and a 5-HT3 blocker (e.g. Patients achieving stable disease or better will undergo surgical resection 4–8 weeks after completion of the first three cycles of treatment. No program-related procedures will be performed until a patient or a patient’s legal representative has given written informed consent. In order to have the chance fully to endorse the use of the nITRO regimen for the perioperative treatment of resectable pancreatic cancer patients, this trial should have had a randomized design by including a standard treatment arm with surgery followed by mFOLFIRINOX postoperative treatment. All characteristics (demographics, medical history, physical examination, vital signs, KPS, ECG, laboratory procedures, tumor assessment, concomitant medication and procedure) will be provided as descriptive statistics in summary tables both at baseline and for each time visit, when appropriate. If the time required for recovery from toxicity is more than 3 weeks, the patient should be discontinued from the program, unless the patient is benefiting from the program treatment. Lei rivelò a lui di essere in Erasmus in Spagna e il ragazzone di Napoli non esitò un attimo a partire per andare a trovarla. Informed consent for translational research studies for patients enrolled in the Nitro trial. Please read and accept the terms and conditions and check the box to generate a sharing link. A total of 72 patients will be enrolled to receive a perioperative treatment of three cycles before and three cycles after surgical resection with nal-IRI 50 mg/m2, oxaliplatin 60 mg/m2, leucovorin 200 mg/m2, and 5-fluorouracil 2400 mg/m2, days 1 and 15 of a 28-day cycle. Standard operating procedures (SOPs) will be interpreted to ensure patient safety and the integrity of the clinical data. Moreover, this study represents a unique opportunity for translational analyses aimed to identify novel immune-related prognostic and predictive factors in this clinical setting. In the first stage, 39 patients will be accrued. Attualmente lavora come Screenwriters & Directors Agent per la TT Agency, agenzia di rappresentanza, consulenza e promozione artistica per attori, sceneggiatori e registi. Does the interval from imaging to operation affect the rate of unanticipated metastasis encountered during operation for pancreatic adenocarcinoma? The study will also evaluate the relationship between plasma PK of nal-IRI (total irinotecan, SN-38), oxaliplatin, 5-FU and efficacy and safety endpoints in resectable pancreatic cancer patients. Monitoring will be carried out in this trial. The email address and/or password entered does not match our records, please check and try again. Treatment with these agents and any others that interact with irinotecan should be avoided whenever possible. Strong CYP3A4 inhibitors and UGT1A1 inhibitors: Patients receiving concomitant non-liposomal irinotecan and ketoconazole, a CYP3A4 and UGT1A1 inhibitor, have increased SN-38 exposure by 109%. Loperamide should be given until patient is without diarrhea for at least 12 h. If diarrhea persists while patient is on loperamide for more than 24 h, adding oral antibiotic support (fluoroquinolone for 7 days) should be considered. Proper execution and documentation of the laboratory procedures is the responsibility of the treating physician. A careful assessment and review is needed to check eligibility and continued participation in the program. Survival data will be reported descriptively and graphically, for each time of follow-up visit (up to 2 years). R0 will be calculated as a binary outcome. Nonetheless, the 3-year disease free survival (DFS) was of nearly 40%, indicating that even in this selected population of good performance status resected patients receiving a triplet chemotherapeutic, more than half of the patients experienced local or metastatic recurrence.12 In interpreting these results, it should, furthermore, be considered that they do not include the overall population of patients undergoing surgical resection. Survival will be estimated by using the Kaplan–Meier method. Visualizza il profilo di Paola Rossi su LinkedIn, la più grande comunità professionale al mondo. Informed consent for screening and enrolling patients in the nITRO trial. FundingThe authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Funding for this study has been provided by an unrestricted research grant by Shire. Physicians should also consider providing patients with an antiemetic regimen for subsequent use, as well as loperamide (or equivalent) for treatment of late diarrhea, if necessary. Willett, CG, Lewandrowski, K, Warshaw, AL. “Genny Savastano”, LA CASA DI CARTA – CONFERMATE LE STAGIONI 5 E 6 – SPOILER, Berlino a suo Fratello Sergio la lettera di addio, Classificazioni Netflix: gli spettacoli più visti del 2020, Gli attori più pagati del 2020: Dwayne Johnson il numero 1, Perchè guardare Gomorra, 5 ottimi motivi per farlo, Matilde Gioli, la ricordate in Gomorra? Nonetheless, we acknowledge some limitations of this study. Therefore, co-administration of nal-IRI with other inhibitors of CYP3A4 (e.g. Bazzichetto, C, Conciatori, F, Luchini, C. Gillen, S, Schuster, T, Büschenfelde, CMZ. Proprio quando si trovava in Spagna per studio, con il progetto Erasmus, Paola ha iniziato a frequentare virtualmente quello che sarebbe poi diventato il suo compagno. Potential predictive and/or prognostic biomarkers (cytokines concentration will be measured using multiplex xMAP/Luminex technology, at baseline and after treatment). LV should be given immediately prior to each 5-FU dose; hence, if the 5-FU dose is held, LV should be held as well.
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